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| ID | Type | Description | Link |
|---|---|---|---|
| A6111100, 912-OPT-0091-131 |
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Non-interventional study to obtain real life data from the treatment with Xalatan and Xalacom in Germany and to assess the long-term efficacy and tolerability under routine conditions. Data were entered into an electronic case report form.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with glaucoma and ocular hypertension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) | Mean IOP values measured by applanation tonometry. Only Goldman values are displayed; if values were given for both right and left eye, the value of the right eye was analyzed. Change (absolute difference) calculated as mean of (value of IOP at observation minus baseline value). Study course is reported by yearly intervals and clustered as 1 year (12±3 months), 2 years (24±3 months), and 3 years (36±3 months). | Baseline, 1 year, 2 years, and 3 years |
| Aulhorn Stage (Visual Field Defects) | Number of subjects at each Aulhorn stage. Staged as: No scotoma; Stage I (relative scotomas only), Stage II (absolute scotomas without connection to the blind spot), Stage III (absolute scotomas with connection to the blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If values were given for both right and left eye, the value of the right eye was analyzed. | Baseline, 1 year, 2 years, and 3 years |
| Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio | Mean vertical cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value). | Baseline, 1 year, 2 years, and 3 years |
| Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio | Mean horizontal cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value). |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Assessment of Xalatan® Efficacy | Number of subjects for Investigator assessment of the efficacy of Xalatan® treatment rated as excellent (highly effective), very good, good, moderate, sufficient, and insufficient (not effective). | Baseline, 1 year, 2 years, and 3 years |
| Subject Assessment of Satisfaction With Xalatan® Treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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patients with glaucoma or ocular hypertension treated by office-based ophthalmologists
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Subjects were assigned to a therapeutic strategy within current practice and not according to a protocol.
Open-label, prospective, multi-center, non-interventional cohort study (NIS) at 385 centers (office-based ophthalmologists); number of subjects per center was not limited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With Glaucoma and Ocular Hypertension | All subjects group: documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups: Xalatan®: subjects with Xalatan® (latanoprost) monotherapy at baseline visit; Betablockers: subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit; Xalacom®: subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit; other medications: subjects with other or no hypotensive therapy at baseline visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Xalatan® | Subjects with Xalatan® (latanoprost) monotherapy at baseline visit |
| BG001 | Betablockers | Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Intraocular Pressure (IOP) | Mean IOP values measured by applanation tonometry. Only Goldman values are displayed; if values were given for both right and left eye, the value of the right eye was analyzed. Change (absolute difference) calculated as mean of (value of IOP at observation minus baseline value). Study course is reported by yearly intervals and clustered as 1 year (12±3 months), 2 years (24±3 months), and 3 years (36±3 months). | All subjects group and each treatment group population. N=number of participants with IOP data at baseline; (n)=number of participants with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively. | Posted | Mean | Standard Deviation | mm Hg | Baseline, 1 year, 2 years, and 3 years |
|
Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | Subjects with documented diagnosis of glaucoma or ocular hypertension at baseline visit. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
Except at baseline, number of subjects analyzed in treatment groups do not necessarily summarize to "All subjects" total; subjects drop out of treatment group when therapy changes. "All subjects" shows all subjects irrespective of any therapy change.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
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| Baseline, 1 year, 2 years, and 3 years |
Number of subjects for assessment of subject satisfaction with Xalatan® treatment; categorized as excellent (full satisfaction), very good, good, moderate, sufficient, and insufficient (no satisfaction). |
| Baseline, 1 year, 2 years, and 3 years |
| Visual Acuity (Visus) | Number of subjects with visual acuity evaluations: amaurosis (partial or total loss of sight); hand movements (able to detect gross object and motion perception without detailed discrimination); finger count (able to count fingers at a given distance); visual acuity scale: range 0.05 (low acuity) to >1.2 (greater acuity). If values were given for both the right eye and left eye, the value of the right eye was analyzed. | Baseline, 1 year, 2 years, and 3 years |
| Visual Impairment Due to Glaucoma | Number of subjects per level of visual impairment categorized as not at all (no impairment), a little bit, moderate, severe, and very severe (very severe impairment). | Baseline, 1 year, 2 years, and 3 years |
| Subject Self-care: Application of Eye Drops | Number of subjects per level of ability for application (administration) of eye drops categorized as without the help of nursing staff (apply without help) and with the help of nursing staff (apply with help). | Baseline, 1 year, 2 years, and 3 years |
| Reasons for Changes in Glaucoma Therapy | Number of subjects for each reason for change of therapy; there may be more than one reason possible per patient. Reasons for changes in glaucoma therapy was reported from January 2000 through December 2008 independent of the duration of any individual subject's time on study. | January 2000 through December 2008 |
| Investigator Assessment of Tolerability of Xalatan® Treatment | Number of subjects for the Investigator's assessment of subjects tolerability of Xalatan® treatment categorized as excellent, very good, good, moderate, sufficient, or insufficient. The occurrence of adverse events (a side effect that may not have any causal relationship to study treatment) was documented as tolerability data. | Baseline up to 3 years |
| Reasons for Discontinuation From Study | Number of subjects per reason for discontinuation from the study. More than one reason for discontinuation is possible per patient. Discontinuation analysis was performed independent of the duration of any individual subject's time on study. | January 2000 through December 2008 |
| Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment | Number of subjects with documented change to the color of the iris during treatment with Xalatan® or Xalacom®. | Baseline up to 3 years |
| BG002 | Xalacom® | Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit |
| BG003 | Other Medication | Subjects with other or no hypotensive therapy at baseline visit |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Concomitant ocular diseases at baseline | Number of subjects per type of concomitant ocular diseases present at baseline visit for right eye (OD) and left eye (OS). Column numbers may not equal the total number of participants analyzed as subjects could meet criteria for more than 1 category. | Number | participants |
|
| Concomitant systemic diseases at baseline | Number of subjects per type of concomitant systemic disease present at baseline visit. Column numbers may not equal the total number of participants analyzed as subjects could meet criteria for more than one category. | Number | participants |
|
| Glaucoma diagnosis at baseline | Number of subjects per each type of glaucoma diagnosis present at baseline visit for OD and OS. Column numbers may not equal the total number of participants analyzed as subjects could meet criteria for more than one category. | Number | participants |
|
| Duration of glaucoma disease at baseline | Duration in years for glaucoma disease present at baseline visit. | Mean | Standard Deviation | years |
|
| OG001 | Xalatan® | Subjects with Xalatan® (latanoprost) monotherapy at baseline visit |
| OG002 | Betablockers | Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit. |
| OG003 | Xalacom® | Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit |
| OG004 | Other Medications | Subjects with other or no hypotensive therapy at baseline visit. |
|
|
|
| Primary | Aulhorn Stage (Visual Field Defects) | Number of subjects at each Aulhorn stage. Staged as: No scotoma; Stage I (relative scotomas only), Stage II (absolute scotomas without connection to the blind spot), Stage III (absolute scotomas with connection to the blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If values were given for both right and left eye, the value of the right eye was analyzed. | All subjects group and all treatment groups populations | Posted | Number | participants | Baseline, 1 year, 2 years, and 3 years |
|
|
|
| Primary | Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio | Mean vertical cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value). | All subjects group and all treatment groups populations. N=number of participants with optic disc excavation data at baseline; (n)=number of participants with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively. | Posted | Mean | Standard Deviation | ratio | Baseline, 1 year, 2 years, and 3 years |
|
|
|
|
| Primary | Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio | Mean horizontal cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value). | All subjects group and all treatment groups populations. N=number of subjects with optic disc excavation data at baseline; (n)=number of subjects with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively. | Posted | Mean | Standard Deviation | ratio | Baseline, 1 year, 2 years, and 3 years |
|
|
|
|
| Secondary | Investigator Assessment of Xalatan® Efficacy | Number of subjects for Investigator assessment of the efficacy of Xalatan® treatment rated as excellent (highly effective), very good, good, moderate, sufficient, and insufficient (not effective). | Xalatan® treatment group only (subjects with Xalatan® monotherapy at baseline visit). | Posted | Number | participants | Baseline, 1 year, 2 years, and 3 years |
|
|
|
| Secondary | Subject Assessment of Satisfaction With Xalatan® Treatment | Number of subjects for assessment of subject satisfaction with Xalatan® treatment; categorized as excellent (full satisfaction), very good, good, moderate, sufficient, and insufficient (no satisfaction). | Xalatan® treatment group only (subjects with Xalatan monotherapy at baseline visit). | Posted | Number | participants | Baseline, 1 year, 2 years, and 3 years |
|
|
|
| Secondary | Visual Acuity (Visus) | Number of subjects with visual acuity evaluations: amaurosis (partial or total loss of sight); hand movements (able to detect gross object and motion perception without detailed discrimination); finger count (able to count fingers at a given distance); visual acuity scale: range 0.05 (low acuity) to >1.2 (greater acuity). If values were given for both the right eye and left eye, the value of the right eye was analyzed. | All subjects group and all treatment groups populations | Posted | Number | participants | Baseline, 1 year, 2 years, and 3 years |
|
|
|
| Secondary | Visual Impairment Due to Glaucoma | Number of subjects per level of visual impairment categorized as not at all (no impairment), a little bit, moderate, severe, and very severe (very severe impairment). | All subjects group; not summarized by subgroups | Posted | Number | participants | Baseline, 1 year, 2 years, and 3 years |
|
|
|
| Secondary | Subject Self-care: Application of Eye Drops | Number of subjects per level of ability for application (administration) of eye drops categorized as without the help of nursing staff (apply without help) and with the help of nursing staff (apply with help). | All subjects group; not summarized by subgroups | Posted | Number | participants | Baseline, 1 year, 2 years, and 3 years |
|
|
|
| Secondary | Reasons for Changes in Glaucoma Therapy | Number of subjects for each reason for change of therapy; there may be more than one reason possible per patient. Reasons for changes in glaucoma therapy was reported from January 2000 through December 2008 independent of the duration of any individual subject's time on study. | Subjects from the all subjects group that changed therapy through the duration of the study; subjects who changed from or changed to "other" therapy (Other Medication) were not included in this analysis; not summarized by subgroups. | Posted | Number | participants | January 2000 through December 2008 |
|
|
|
| Secondary | Investigator Assessment of Tolerability of Xalatan® Treatment | Number of subjects for the Investigator's assessment of subjects tolerability of Xalatan® treatment categorized as excellent, very good, good, moderate, sufficient, or insufficient. The occurrence of adverse events (a side effect that may not have any causal relationship to study treatment) was documented as tolerability data. | Xalatan® treatment group only (subjects with Xalatan monotherapy at baseline visit). | Posted | Number | participants | Baseline up to 3 years |
|
|
|
| Secondary | Reasons for Discontinuation From Study | Number of subjects per reason for discontinuation from the study. More than one reason for discontinuation is possible per patient. Discontinuation analysis was performed independent of the duration of any individual subject's time on study. | Subjects from the All subjects group population who discontinued the study. | Posted | Number | participants | January 2000 through December 2008 |
|
|
|
| Secondary | Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment | Number of subjects with documented change to the color of the iris during treatment with Xalatan® or Xalacom®. | Xalatan® treatment group (subjects with Xalatan® (latanoprost) monotherapy at baseline visit) and Xalacom® treatment group (latanoprost + timolol maleate) therapy at baseline visit. During the course of the study the data structure (scaling of color) was changed in a way that change in iris color was no longer evaluable; data not summarized. | Posted | Baseline up to 3 years |
|
|
| 0 |
| 28,812 |
| 6,936 |
| 28,812 |
| Aortic valve stenosis | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cardiac discomfort | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cyanosis | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
|
| Anophthalmos | Congenital, familial and genetic disorders | MedDRA (12.1) | Systematic Assessment |
|
| Developmental glaucoma | Congenital, familial and genetic disorders | MedDRA (12.1) | Systematic Assessment |
|
| Distichiasis | Congenital, familial and genetic disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA (12.1) | Systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA (12.1) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (12.1) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (12.1) | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA (12.1) | Systematic Assessment |
|
| Abnormal sensation in eye | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Accommodation disorder | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Acquired corneal dystrophy | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Amblyopia | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Angle closure glaucoma | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Anterior capsule contraction | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Anterior chamber disorder | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Astigmatism | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Chalazion | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Conjunctival irritation | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Conjunctival oedema | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Conjunctival pigmentation | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Corneal decompensation | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Corneal defect | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Corneal disorder | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Corneal epithelium defect | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Corneal erosion | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Corneal hypertrophy | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Corneal infiltrates | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Corneal oedema | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Corneal opacity | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Corneal pigmentation | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Corneal thinning | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cyanopsia | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dark circles under eyes | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Ectropion | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eczema eyelids | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Entropion | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Erythema of eyelid | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eye inflammation | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eye oedema | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eyelash discolouration | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eyelid sensory disorder | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eyelids pruritus | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Growth of eyelashes | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hypermetropia | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hyphaema | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hypoaesthesia eye | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Iris disorder | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Iris hyperpigmentation | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Iris hypopigmentation | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Iritis | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Keratoconjunctivitis sicca | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Macular degeneration | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Maculopathy | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Miosis | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Mydriasis | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Myodesopsia | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Myopia | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Night blindness | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Optic disc haemorrhage | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Optic nerve cupping | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Posterior capsule opacification | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Presbyopia | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pterygium | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pupils unequal | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Retinal vein occlusion | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Retinal vein thrombosis | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Scleral discolouration | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Scotoma | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Sicca syndrome | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Strabismus | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Trichiasis | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Vitreous opacities | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Gastric disorder | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Tongue dry | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Death | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Drug intolerance | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Mucosal dryness | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Corneal graft rejection | Immune system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Multiple allergies | Immune system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Reaction to preservatives | Immune system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Sarcoidosis | Immune system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Adenoviral conjunctivitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Herpes ophthalmic | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Corneal scar | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Heart rate decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Intraocular pressure decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Intraocular pressure fluctuation | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Thyroid function test normal | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
|
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
|
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cerebellar ischaemia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cerebrosclerosis | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Senile dementia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Trigeminal neuralgia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Affect lability | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Emotional distress | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Neurosis | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
|
| Renal pain | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (12.1) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hair growth abnormal | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hypertrichosis | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Ingrown hair | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Yellow skin | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Treatment noncompliance | Social circumstances | MedDRA (12.1) | Systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
|
| Corneal transplant | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
|
| Eye excision | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
|
| Eye laser surgery | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
|
| Eye operation | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
|
| Eye prosthesis insertion | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
|
| Intraocular lens implant | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
|
| Photocoagulation | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
|
| Angiosclerosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
| Blood pressure inadequately controlled | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
| Raynaud's phenomenon | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Baseline: Stage I |
|
| Baseline: Stage II |
|
| Baseline: Stage III |
|
| Baseline: Stage IV |
|
| Baseline: Stage V |
|
| Baseline: missing values |
|
| 1 year: No scotoma |
|
| 1 year: Stage I |
|
| 1 year: Stage II |
|
| 1 year: Stage III |
|
| 1 year: Stage IV |
|
| 1 year: Stage V |
|
| 1 year: missing values |
|
| 2 years: No scotoma |
|
| 2 years: Stage I |
|
| 2 years: Stage II |
|
| 2 years: Stage III |
|
| 2 years: Stage IV |
|
| 2 years: Stage V |
|
| 2 years: missing values |
|
| 3 years: No scotoma |
|
| 3 years: Stage I |
|
| 3 years: Stage II |
|
| 3 years: Stage III |
|
| 3 years: Stage IV |
|
| 3 years: Stage V |
|
| 3 years: missing values |
|
| 2 years (n=8088, 3128, 26, 93, 1756) |
|
| 3 years (n=5784, 2173, 16, 34, 1170) |
|
| Mean value |
| 0.44 |
| Standard Deviation |
| 0.24 |
| 95 |
| 0.43 |
| 0.44 |
| Superiority or Other (legacy) |
| Vertical C/D ratio 1 year (n=88) | Mean value | 0.39 | Standard Deviation | 0.19 | 95 | 0.35 | 0.43 | Superiority or Other (legacy) |
| Vertical C/D ratio 1 year (n=241) | Mean value | 0.50 | Standard Deviation | 0.24 | 95 | 0.47 | 0.53 | Superiority or Other (legacy) |
| Vertical C/D ratio 1 year (n=2949) | Mean value | 0.51 | Standard Deviation | 0.27 | 95 | 0.50 | 0.52 | Superiority or Other (legacy) |
| Vertical C/D ratio 2 years (n=8783) | Mean value | 0.46 | Standard Deviation | 0.25 | 95 | 0.46 | 0.47 | Superiority or Other (legacy) |
| Vertical C/D ratio 2 years (n=3396) | Mean value | 0.43 | Standard Deviation | 0.23 | 95 | 0.42 | 0.44 | Superiority or Other (legacy) |
| Vertical C/D ratio 2 years (n=31) | Mean value | 0.39 | Standard Deviation | 0.16 | 95 | 0.33 | 0.45 | Superiority or Other (legacy) |
| Vertical C/D ratio 2 years (n=95) | Mean value | 0.49 | Standard Deviation | 0.24 | 95 | 0.44 | 0.54 | Superiority or Other (legacy) |
| Vertical C/D ratio 2 years (n=1934) | Mean value | 0.51 | Standard Deviation | 0.27 | 95 | 0.50 | 0.53 | Superiority or Other (legacy) |
| Vertical C/D ratio 3 years (n=6344) | Mean value | 0.45 | Standard Deviation | 0.24 | 95 | 0.44 | 0.45 | Superiority or Other (legacy) |
| Vertical C/D ratio 3 years (n=2372) | Mean value | 0.42 | Standard Deviation | 0.22 | 95 | 0.41 | 0.43 | Superiority or Other (legacy) |
| Vertical C/D ratio 3 years (n=25) | Mean value | 0.33 | Standard Deviation | 0.14 | 95 | 0.27 | 0.39 | Superiority or Other (legacy) |
| Vertical C/D ratio 3 years (n=36) | Mean value | 0.47 | Standard Deviation | 0.18 | 95 | 0.41 | 0.53 | Superiority or Other (legacy) |
| Vertical C/D ratio 3 years (n=1283) | Mean value | 0.49 | Standard Deviation | 0.26 | 95 | 0.48 | 0.51 | Superiority or Other (legacy) |
| 2 years (n=7727, 3003, 26, 88, 1630) |
|
| 3 years (n=5500, 2089, 16, 33, 1067) |
|
| Mean value |
| 0.42 |
| Standard Deviation |
| 0.23 |
| 95 |
| 0.42 |
| 0.43 |
| Superiority or Other (legacy) |
| Horizontal C/D ratio 1 year (n=87) | Mean value | 0.37 | Standard Deviation | 0.19 | 95 | 0.33 | 0.42 | Superiority or Other (legacy) |
| Horizontal C/D ratio 1 year (n=232) | Mean value | 0.50 | Standard Deviation | 0.25 | 95 | 0.47 | 0.53 | Superiority or Other (legacy) |
| Horizontal C/D ratio 1 year (n=2703) | Mean value | 0.51 | Standard Deviation | 0.27 | 95 | 0.50 | 0.52 | Superiority or Other (legacy) |
| Horizontal C/D ratio 2 years (n=8427) | Mean value | 0.45 | Standard Deviation | 0.25 | 95 | 0.44 | 0.45 | Superiority or Other (legacy) |
| Horizontal C/D ratio 2 years (n=3276) | Mean value | 0.41 | Standard Deviation | 0.23 | 95 | 0.40 | 0.42 | Superiority or Other (legacy) |
| Horizontal C/D ratio 2 years (n=31) | Mean value | 0.38 | Standard Deviation | 0.19 | 95 | 0.31 | 0.45 | Superiority or Other (legacy) |
| Horizontal C/D ratio 2 years (n=92) | Mean value | 0.50 | Standard Deviation | 0.25 | 95 | 0.45 | 0.56 | Superiority or Other (legacy) |
| Horizontal C/D ratio 2 years (n=1812) | Mean value | 0.51 | Standard Deviation | 0.27 | 95 | 0.49 | 0.52 | Superiority or Other (legacy) |
| Horizontal C/D ratio 3 years (n=6102) | Mean value | 0.43 | Standard Deviation | 0.24 | 95 | 0.43 | 0.44 | Superiority or Other (legacy) |
| Horizontal C/D ratio 3 years (n=2289) | Mean value | 0.40 | Standard Deviation | 0.22 | 95 | 0.39 | 0.41 | Superiority or Other (legacy) |
| Horizontal C/D ratio 3 years (n=25) | Mean value | 0.31 | Standard Deviation | 0.15 | 95 | 0.25 | 0.38 | Superiority or Other (legacy) |
| Horizontal C/D ratio 3 years (n=35) | Mean value | 0.49 | Standard Deviation | 0.21 | 95 | 0.42 | 0.57 | Superiority or Other (legacy) |
| Horizontal C/D ratio 3 years (n=1204) | Mean value | 0.48 | Standard Deviation | 0.26 | 95 | 0.47 | 0.50 | Superiority or Other (legacy) |
| Title | Measurements |
|---|---|
|
| Baseline: Moderate |
|
| Baseline: Sufficient |
|
| Baseline: Insufficient |
|
| Baseline: missing values |
|
| 1 year: Excellent |
|
| 1 year: Very good |
|
| 1 year: Good |
|
| 1 year: Moderate |
|
| 1 year: Sufficient |
|
| 1 year: Insufficient |
|
| 1 year: missing values |
|
| 2 years: Excellent |
|
| 2 years: Very good |
|
| 2 years: Good |
|
| 2 years: Moderate |
|
| 2 years: Sufficient |
|
| 2 years: Insufficient |
|
| 2 years: missing values |
|
| 3 years: Excellent |
|
| 3 years: Very good |
|
| 3 years: Good |
|
| 3 years: Moderate |
|
| 3 years: Sufficient |
|
| 3 years: Insufficient |
|
| 3 years: missing values |
|
| Title | Measurements |
|---|---|
|
| Baseline: Moderate |
|
| Baseline: Sufficient |
|
| Baseline: Insufficient |
|
| Baseline: missing values |
|
| 1 year: Excellent |
|
| 1 year: Very good |
|
| 1 year: Good |
|
| 1 year: Moderate |
|
| 1 year: Sufficient |
|
| 1 year: Insufficient |
|
| 1 year: missing values |
|
| 2 years: Excellent |
|
| 2 years: Very good |
|
| 2 years: Good |
|
| 2 years: Moderate |
|
| 2 years: Sufficient |
|
| 2 years: Insufficient |
|
| 2 years: missing values |
|
| 3 years: Excellent |
|
| 3 years: Very good |
|
| 3 years: Good |
|
| 3 years: Moderate |
|
| 3 years: Sufficient |
|
| 3 years: Insufficient |
|
| 3 years: missing values |
|
| Baseline: Hand movements |
|
| Baseline: Finger count |
|
| Baseline: 0.05 |
|
| Baseline: 0.1 |
|
| Baseline: 0.2 |
|
| Baseline: 0.3 |
|
| Baseline: 0.4 |
|
| Baseline: 0.5 |
|
| Baseline: 0.6 |
|
| Baseline: 0.7 |
|
| Baseline: 0.8 |
|
| Baseline: 0.9 |
|
| Baseline: 1.0 |
|
| Baseline: 1.1 |
|
| Baseline: 1.2 |
|
| Baseline: >1.2 |
|
| Baseline: Missing values |
|
| 1 year: Amaurosis |
|
| 1 year: Hand movements |
|
| 1 year: Finger counts |
|
| 1 year: 0.05 |
|
| 1 year: 0.1 |
|
| 1 year: 0.2 |
|
| 1 year: 0.3 |
|
| 1 year: 0.4 |
|
| 1 year: 0.5 |
|
| 1 year: 0.6 |
|
| 1 year: 0.7 |
|
| 1 year: 0.8 |
|
| 1 year: 0.9 |
|
| 1 year: 1.0 |
|
| 1 year: 1.1 |
|
| 1 year: 1.2 |
|
| 1 year: >1.2 |
|
| 1 year: Missing values |
|
| 2 years: Amaurosis |
|
| 2 years: Hand movements |
|
| 2 years: Finger counts |
|
| 2 years: 0.05 |
|
| 2 years: 0.1 |
|
| 2 years: 0.2 |
|
| 2 years: 0.3 |
|
| 2 years: 0.4 |
|
| 2 years: 0.5 |
|
| 2 years: 0.6 |
|
| 2 years: 0.7 |
|
| 2 years: 0.8 |
|
| 2 years: 0.9 |
|
| 2 years 1.0 |
|
| 2 years: 1.1 |
|
| 2 years: 1.2 |
|
| 2 years: >1.2 |
|
| 2 years: Missing values |
|
| 3 years: Amaurosis |
|
| 3 years: Hand movements |
|
| 3 years: Finger counts |
|
| 3 years: 0.05 |
|
| 3 years: 0.1 |
|
| 3 years: 0.2 |
|
| 3 years: 0.3 |
|
| 3 years: 0.4 |
|
| 3 years: 0.5 |
|
| 3 years: 0.6 |
|
| 3 years: 0.7 |
|
| 3 years: 0.8 |
|
| 3 years: 0.9 |
|
| 3 years: 1.0 |
|
| 3 years: 1.1 |
|
| 3 years: 1.2 |
|
| 3 years: >1.2 |
|
| 3 years: Missing values |
|
| Title | Measurements |
|---|
|
| Baseline: Severe |
|
| Baseline: Very severe |
|
| Baseline: Missing values |
|
| 1 year: Not at all |
|
| 1 year: A little bit |
|
| 1 year: Moderate |
|
| 1 year: Severe |
|
| 1 year: Very severe |
|
| 1 year: Missing values |
|
| 2 years: Not at all |
|
| 2 years: A little bit |
|
| 2 years: Moderate |
|
| 2 years: Severe |
|
| 2 years: Very severe |
|
| 2 years: Missing values |
|
| 3 years: Not at all |
|
| 3 years: A little bit |
|
| 3 years: Moderate |
|
| 3 years: Severe |
|
| 3 years: Very severe |
|
| 3 years: Missing values |
|
| Title | Measurements |
|---|---|
|
| 1 year: apply without help |
|
| 1 year: apply with help |
|
| 1 year: missing values |
|
| 2 years: apply without help |
|
| 2 years: apply with help |
|
| 2 years: missing values |
|
| 3 years: apply without help |
|
| 3 years: apply with help |
|
| 3 years: missing values |
|
| Title | Measurements |
|---|---|
|
| Wish for better systemic tolerability |
|
| No medication until now |
|
| Other reason |
|
| Missing values |
|
| Title | Measurements |
|---|---|
|
| Baseline: Moderate |
|
| Baseline: Sufficient |
|
| Baseline: Insufficient |
|
| Baseline: Missing values |
|
| 1 year: Excellent |
|
| 1 year: Very good |
|
| 1 year: Good |
|
| 1 year: Moderate |
|
| 1 year: Sufficient |
|
| 1 year: Insufficient |
|
| 1 year: Missing values |
|
| 2 years: Excellent |
|
| 2 years: Very good |
|
| 2 years: Good |
|
| 2 years: Moderate |
|
| 2 years: Sufficient |
|
| 2 years: Insufficient |
|
| 2 years: Missing values |
|
| 3 years: Excellent |
|
| 3 years: Very good |
|
| 3 years: Good |
|
| 3 years: Moderate |
|
| 3 years: Sufficient |
|
| 3 years: Insufficient |
|
| 3 years: Missing values |
|
| Title | Measurements |
|---|---|
|
| Adverse event |
|
| Other reason |
|