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The purpose of this study is to clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population.
Patients will be examined pre-operatively to up to 3 years post-operatively. One eligible eye will be selected as a target eye for efficacy analysis. If both eyes are eligible, the eye in which the IOL is implanted first will be selected as the target eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acrysof IQ Toric A-code IOL | Experimental | IOL implanted during cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof IQ Toric A-code IOL | Device | Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4) | IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. No confirmatory hypothesis testing was conducted. | Visit 00 (Day 0 operative), Visit 4 (Day 120-180 postoperative) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With Absolute Value of IOL Rotation From Visit 00 | IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at the specified visit and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Expert Clinical Project Lead, CDMA Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Hiroshima | Hiroshima | 733-0842 | Japan | ||
| Alcon Investigative Site |
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Of the 125 subjects enrolled, 4 were exited as screen failures prior to implantation with the test article. This reporting group includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye) (Safety Analysis Set).
Subjects were enrolled at 4 investigative sites located in Japan.
| ID | Title | Description |
|---|---|---|
| FG000 | AcrySof IQ Toric A-code IOL | AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Acrysof IQ Toric A-code IOL | AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye |
| 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 | Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4) | IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. No confirmatory hypothesis testing was conducted. | All Implanted Analysis Set: All eyes with successful test article implantation and measurable data at Visit 4. | Posted | Number | percentage of eyes | Visit 00 (Day 0 operative), Visit 4 (Day 120-180 postoperative) | eye | eye |
|
Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
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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 | Acrysof IQ Toric A-code IOL | AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted unilaterally |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral infarction | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Posterior capsule opacification | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Expert Clinical Project Lead, CDMA Surgical | Alcon Research | 1-888-451-3937 | alcon.medinfo@alcon.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 16, 2021 | Nov 18, 2022 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2017 | Nov 18, 2022 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| Cataract surgery | Procedure | Removal of cataractous lens and implantation of IOL |
|
| Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140) |
| Mean Absolute Value of IOL Rotation From Visit 00 | IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle on the IOL at the specified visit and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. | Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140) |
| Mean Uncorrected Distance Visual Acuity (UCDVA) by Visit | Visual acuity (VA) was tested under well-lit conditions with no refractive correction in place using a decimal visual acuity chart set at 5 meters. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. A negative value denotes better than 20/20 visual acuity. | Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140) |
| Mean Best Corrected Distance Visual Acuity (BCDVA) by Visit | Visual acuity (VA) was tested under well-lit conditions with refractive correction in place using a decimal visual acuity chart set at 5 meters. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. A negative value denotes better than 20/20 visual acuity. | Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140) |
| Mean Sub-Surface Nano Glistening (SSNG) Densitometry (Peak) by Visit | Sub-surface nano glistening (SSNG) densitometry was measured as the IOL anterior surface light scattering densitometry using Pentacam or Pentacam HR. SSNG was measured in units specific to the device, with a higher number indicating a higher presence of SSNG. Peak value is the highest value in the IOL anterior surface light scattering densitometry. | Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140) |
| Mean SSNG Densitometry (Area Analysis) by Visit | Sub-surface nano glistening (SSNG) densitometry was measured as the IOL anterior surface light scattering densitometry using Pentacam or Pentacam HR. SSNG was measured in units specific to the device, with a higher number indicating a higher presence of SSNG. Area analysis value is an average value of the IOL anterior surface light scattering densitometry in a certain area. | Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140) |
| Number of Device Deficiencies | A device deficiency was defined as an inadequacy of the medical device with respect to its identity, quality, durability, reliability, safety, or performance. | Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140) |
| Percentage of Eyes With Glistening by Visit | A slit lamp examination was conducted to determine the presence/absence of glistening particles on the implanted IOL. Glistening was reported by on a 4-point scale, where Grade 0 = no glistening; Grade 1 = mild glistening (50/mm3); Grade 2 = moderate glistening (100/mm3); and Grade 3 = severe glistening (200/mm3). | Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140) |
| Number of Eyes With Posterior Capsule Opacification (PCO) by Visit | A slit lamp examination was performed to evaluate the eye for posterior capsule opacification (that is, the thickening, opacification and clouding of the posterior lens capsule). The presence or absence of PCO was recorded. Clinical significance was determined by the investigator. | Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140), Unscheduled Visits between Visit 1 and Visit 7 |
| Number of Eyes Receiving Nd:YAG Laser Treatment for Posterior Capsule Opacification (PCO) by Visit | A slit lamp examination was performed to evaluate the eye for posterior capsule opacification (that is, the thickening, opacification and clouding of the posterior lens capsule). A neodymium-doped yttrium aluminum garnet (Nd:YAG) laser was used to treat posterior capsule opacification, with treatment determined by the investigator. The presence or absence of Nd:YAG laser treament was recorded. | Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140), Unscheduled Visits between Visit 1 and Visit 7 |
| Hakodate |
| Hokkaido |
| 040-0053 |
| Japan |
| Alcon Investigative Site | Miyakonojō | Miyazaki | 885-0051 | Japan |
| Alcon Investigative Site | Saga | Saga-ken | 840-0831 | Japan |
| Physician Decision |
|
| years |
|
| Age, Customized | Count of Participants | Participants | No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| eye |
|
|
| Other Pre-specified | Percentage of Eyes With Absolute Value of IOL Rotation From Visit 00 | IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at the specified visit and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. | All Implanted Analysis Set: All eyes with successful test article implantation and measurable data at both visits. | Posted | Number | percentage of eyes | Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140) | eye | eye |
|
|
|
| Other Pre-specified | Mean Absolute Value of IOL Rotation From Visit 00 | IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle on the IOL at the specified visit and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. | All Implanted Analysis Set: All eyes with successful test article implantation and measurable data at both visits. | Posted | Mean | Standard Deviation | degree | Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140) | eye | eye |
|
|
|
| Other Pre-specified | Mean Uncorrected Distance Visual Acuity (UCDVA) by Visit | Visual acuity (VA) was tested under well-lit conditions with no refractive correction in place using a decimal visual acuity chart set at 5 meters. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. A negative value denotes better than 20/20 visual acuity. | All Implanted Analysis Set: All eyes with successful test article implantation | Posted | Mean | Standard Deviation | logMAR | Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140) | eye | eye |
|
|
|
| Other Pre-specified | Mean Best Corrected Distance Visual Acuity (BCDVA) by Visit | Visual acuity (VA) was tested under well-lit conditions with refractive correction in place using a decimal visual acuity chart set at 5 meters. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. A negative value denotes better than 20/20 visual acuity. | All Implanted Analysis Set: All eyes with successful test article implantation | Posted | Mean | Standard Deviation | logMAR | Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140) | eye | eye |
|
|
|
| Other Pre-specified | Mean Sub-Surface Nano Glistening (SSNG) Densitometry (Peak) by Visit | Sub-surface nano glistening (SSNG) densitometry was measured as the IOL anterior surface light scattering densitometry using Pentacam or Pentacam HR. SSNG was measured in units specific to the device, with a higher number indicating a higher presence of SSNG. Peak value is the highest value in the IOL anterior surface light scattering densitometry. | All Implanted Analysis Set: All eyes with successful test article implantation | Posted | Mean | Standard Deviation | arbitrary units | Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140) | eye | eye |
|
|
|
| Other Pre-specified | Mean SSNG Densitometry (Area Analysis) by Visit | Sub-surface nano glistening (SSNG) densitometry was measured as the IOL anterior surface light scattering densitometry using Pentacam or Pentacam HR. SSNG was measured in units specific to the device, with a higher number indicating a higher presence of SSNG. Area analysis value is an average value of the IOL anterior surface light scattering densitometry in a certain area. | All Implanted Analysis Set: All eyes with successful test article implantation | Posted | Mean | Standard Deviation | arbitrary units | Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140) | eye | eye |
|
|
|
| Other Pre-specified | Number of Device Deficiencies | A device deficiency was defined as an inadequacy of the medical device with respect to its identity, quality, durability, reliability, safety, or performance. | Safety Analysis Set | Posted | Number | device deficiency | Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140) | eye | eye |
|
|
|
| Other Pre-specified | Percentage of Eyes With Glistening by Visit | A slit lamp examination was conducted to determine the presence/absence of glistening particles on the implanted IOL. Glistening was reported by on a 4-point scale, where Grade 0 = no glistening; Grade 1 = mild glistening (50/mm3); Grade 2 = moderate glistening (100/mm3); and Grade 3 = severe glistening (200/mm3). | Safety Analysis Set: All eyes with attempted implantation with the test article (successful or aborted after contact with the eye). Note: One subject implanted with the test article discontinued the study prior to the Visit 1 assessment. | Posted | Number | percentage of eyes | Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140) | eye | eye |
|
|
|
| Other Pre-specified | Number of Eyes With Posterior Capsule Opacification (PCO) by Visit | A slit lamp examination was performed to evaluate the eye for posterior capsule opacification (that is, the thickening, opacification and clouding of the posterior lens capsule). The presence or absence of PCO was recorded. Clinical significance was determined by the investigator. | Safety Analysis Set: All eyes with attempted implantation with the test article (successful or aborted after contact with the eye). Note: One subject implanted with the test article discontinued the study prior to the Visit 1 assessment. | Posted | Number | eye | Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140), Unscheduled Visits between Visit 1 and Visit 7 | eye | eye |
|
|
|
| Other Pre-specified | Number of Eyes Receiving Nd:YAG Laser Treatment for Posterior Capsule Opacification (PCO) by Visit | A slit lamp examination was performed to evaluate the eye for posterior capsule opacification (that is, the thickening, opacification and clouding of the posterior lens capsule). A neodymium-doped yttrium aluminum garnet (Nd:YAG) laser was used to treat posterior capsule opacification, with treatment determined by the investigator. The presence or absence of Nd:YAG laser treament was recorded. | Safety Analysis Set: All eyes with attempted implantation with the test article (successful or aborted after contact with the eye). Note: One subject implanted with the test article discontinued the study prior to the Visit 1 assessment. | Posted | Number | eye | Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140), Unscheduled Visits between Visit 1 and Visit 7 | eye | eye |
|
|
|
| 4 |
| 121 |
| 15 |
| 121 |
| 7 |
| 121 |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Haemmorhoids | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Bladder prolapse | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dermatochalasis | Eye disorders | MedDRA 22.0 | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| eye |
|
| Greater than or equal to 10 degrees rotation |
|
| Less than 20 degrees rotation |
|
| Greater than or equal to 20 degrees rotation |
|
| Less than 30 degrees rotation |
|
| Greater than or equal to 30 degrees rotation |
|
| eye |
|
| eye |
|
| eye |
|
| eye |
|
| eye |
|
| Title | Measurements |
|---|---|
|
| IOL dislocation |
|
| Other: IOL rotation |
|
| eye |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| eye |
|
| Clinically nonsignificant |
|
| Clinically significant |
|
| Clinically significant requiring Nd:YAG laser treatment |
|
| eye |
|
| Yes |
|