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The purpose of this study is to confirm the effectiveness of the investigational lens in a Korean population, especially for visual performance, quality of vision, and subject satisfaction with the visual outcome, as well as the safety of the lens. This trial will be conducted in Korea.
Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 9 study visits over a 4-5-month period. Of these 9 visits, 1 is preoperative, 2 are operative, and the remaining 6 are postoperative visits. Primary endpoint data will be collected at the Month 3 visit (Day 90-120 post second eye implantation). The second eye implantation will occur 2-30 days after the first implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifocal IOL | Experimental | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes will be implanted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof IQ PanOptix Multifocal IOL | Device | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision intended for long-term use over the lifetime of the cataract subject |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Defocus Curve at Month 3 | The defocus curve (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best distance correction across full range varied from +2.0 diopter (D) to -5.0 D in 0.5 D increments. The visual acuity (VA) at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better VA. No formal statistical hypothesis testing was planned. | Month 3 (Day 90-120 post second eye implantation) |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Defocus Curve at Month 1 | The defocus curve (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best distance correction across full range varied from +2.0 diopter (D) to -5.0 D in 0.5 D increments. VA at each spherical power was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better VA. No formal statistical hypothesis testing was planned. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alcon Research | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Seongnam-si | 13620 | South Korea | |||
| Alcon Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32669090 | Derived | Kim TI, Chung TY, Kim MJ, Lee K, Hyon JY. Visual outcomes and safety after bilateral implantation of a trifocal presbyopia correcting intraocular lens in a Korean population: a prospective single-arm study. BMC Ophthalmol. 2020 Jul 15;20(1):288. doi: 10.1186/s12886-020-01549-z. |
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Of the 52 enrolled, 7 subjects exited as screen failures prior to implantation. This reporting group includes all implanted subjects (45).
Subjects were recruited from 4 study centers located in Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | TFNT00 | AcrySof IQ PanOptix Multifocal intraocular lens (IOL) Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis population included all subjects with attempted IOL implantation (successful or aborted after contact with the eye) (Safety Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | TFNT00 | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted |
| 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 | Binocular Defocus Curve at Month 3 | The defocus curve (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best distance correction across full range varied from +2.0 diopter (D) to -5.0 D in 0.5 D increments. The visual acuity (VA) at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better VA. No formal statistical hypothesis testing was planned. | This analysis population included all subjects with successful bilateral IOL implantation (Full Analysis Set). Number analyzed is the number of subjects with data available for analysis at specified defocus. | Posted | Mean | Standard Deviation | logMAR | Month 3 (Day 90-120 post second eye implantation) |
|
Pre-operation through study completion, an average of 7 months
Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
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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 | Preoperative | All subjects in the safety analysis set prior to initiation of treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA (21.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical/Brand Lead | 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 | Dec 13, 2017 | May 21, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 27, 2018 | May 21, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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|
| Month 1 (Day 30-60 post second eye implantation) |
| Binocular Best Corrected Distance Visual Acuity (BCDVA) [4 Meters (m)] | VA was tested binocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters from the spectacle plane. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) |
| Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) | VA was tested monocularly (each eye separately) under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 4 m from the eye, corresponding to a far distance for visual tasks. UCDVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) |
| Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)] | VA was tested monocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 60 cm from the eye, representative of intermediate distances for visual tasks. UCIVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) |
| Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) | VA was tested monocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 40 cm from the eye, representative of near distances for visual tasks. UCNVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) |
| Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) | VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 4 m from the eye, corresponding to a far distance for visual tasks. UCDVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) |
| Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) | VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 60 cm from the eye, representative of intermediate distances for visual tasks. UCIVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) |
| Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) | VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 40 cm from the eye, representative of near distances for visual tasks. UCNVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) |
| Binocular Photopic Best Corrected Contrast Sensitivity With Glare | Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed binocularly under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with a glare source. A higher numeric value will represent better contrast sensitivity. No formal statistical hypothesis testing was planned. | Month 3 (Day 90-120 post second eye implantation) |
| Binocular Photopic Best Corrected Contrast Sensitivity Without Glare | Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed binocularly under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, 12, and 18 cpd using the Vector Vision CSV 1000-HGT without a glare source. A higher numeric value will represent better contrast sensitivity. No formal statistical hypothesis testing was planned. | Month 3 (Day 90-120 post second eye implantation) |
| Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Subjects responded to 12 SSQs based on their experience during past 7 days for quality of vision and any change since cataract surgery as follows; Q1:How satisfied are you with your vision for seeing objects at near distance(ND)? Q2:How often do you wear eyeglasses or contact lenses for seeing objects at ND? Q3:How satisfied are you with your vision for seeing objects at intermediate distance(ID)? Q4:How often do you wear eyeglasses or contact lens for seeing objects at ID? Q5:How satisfied are you with your vision for seeing objects at distance(D)? Q6:How often do you wear eyeglasses or contact lens for seeing objects at D? Q7:How often do you experience halos? Q8:How severe were these halos? Q9:If you CURRENTLY DRIVE: how much difficulty do you have driving at night? Q10:If you DO NOT DRIVE at night, what is the reason? Q11:How satisfied are you with your cataract surgery result? Q12:Would you recommend cataract surgery and new lenses that were put into your eyes to other people? | Preoperative and Month 3 (Day 90-120 post second eye implantation) |
| Seoul |
| 03722 |
| South Korea |
| Alcon Investigative Site | Seoul | 05505 | South Korea |
| Alcon Investigative Site | Seoul | 06351 | South Korea |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted |
|
|
| Secondary | Binocular Defocus Curve at Month 1 | The defocus curve (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best distance correction across full range varied from +2.0 diopter (D) to -5.0 D in 0.5 D increments. VA at each spherical power was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better VA. No formal statistical hypothesis testing was planned. | Full Analysis Set. Number analyzed is the number of subjects with data available for analysis at specified defocus. | Posted | Mean | Standard Deviation | logMAR | Month 1 (Day 30-60 post second eye implantation) |
|
|
|
| Secondary | Binocular Best Corrected Distance Visual Acuity (BCDVA) [4 Meters (m)] | VA was tested binocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters from the spectacle plane. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Full Analysis Set. Number analyzed is the number of subjects with data available for analysis at specified time point. | Posted | Mean | Standard Deviation | logMAR | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) |
|
|
|
| Secondary | Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) | VA was tested monocularly (each eye separately) under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 4 m from the eye, corresponding to a far distance for visual tasks. UCDVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | This analysis population included all subjects with successful implantation of the test product in at least one eye (All-implanted Analysis Set). Number analyzed is the number of subjects/eyes with data available for analysis at specified time point. | Posted | Mean | Standard Deviation | logMAR | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) | Eyes | Eyes |
|
|
|
| Secondary | Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)] | VA was tested monocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 60 cm from the eye, representative of intermediate distances for visual tasks. UCIVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | All-implanted Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified time point. | Posted | Mean | Standard Deviation | logMAR | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) | Eyes | Eyes |
|
|
|
| Secondary | Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) | VA was tested monocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 40 cm from the eye, representative of near distances for visual tasks. UCNVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | All-implanted Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified time point. | Posted | Mean | Standard Deviation | logMAR | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) | Eyes | Eyes |
|
|
|
| Secondary | Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) | VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 4 m from the eye, corresponding to a far distance for visual tasks. UCDVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Full Analysis Set. Number analyzed is the number of subjects with data available for analysis at specified time point. | Posted | Mean | Standard Deviation | logMAR | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) |
|
|
|
| Secondary | Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) | VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 60 cm from the eye, representative of intermediate distances for visual tasks. UCIVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Full Analysis Set | Posted | Mean | Standard Deviation | logMAR | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) |
|
|
|
| Secondary | Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) | VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 40 cm from the eye, representative of near distances for visual tasks. UCNVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Full Analysis Set | Posted | Mean | Standard Deviation | logMAR | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) |
|
|
|
| Secondary | Binocular Photopic Best Corrected Contrast Sensitivity With Glare | Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed binocularly under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with a glare source. A higher numeric value will represent better contrast sensitivity. No formal statistical hypothesis testing was planned. | Full Analysis Set | Posted | Mean | Standard Deviation | log unit | Month 3 (Day 90-120 post second eye implantation) |
|
|
|
| Secondary | Binocular Photopic Best Corrected Contrast Sensitivity Without Glare | Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed binocularly under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, 12, and 18 cpd using the Vector Vision CSV 1000-HGT without a glare source. A higher numeric value will represent better contrast sensitivity. No formal statistical hypothesis testing was planned. | Full Analysis Set | Posted | Mean | Standard Deviation | log unit | Month 3 (Day 90-120 post second eye implantation) |
|
|
|
| Secondary | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Subjects responded to 12 SSQs based on their experience during past 7 days for quality of vision and any change since cataract surgery as follows; Q1:How satisfied are you with your vision for seeing objects at near distance(ND)? Q2:How often do you wear eyeglasses or contact lenses for seeing objects at ND? Q3:How satisfied are you with your vision for seeing objects at intermediate distance(ID)? Q4:How often do you wear eyeglasses or contact lens for seeing objects at ID? Q5:How satisfied are you with your vision for seeing objects at distance(D)? Q6:How often do you wear eyeglasses or contact lens for seeing objects at D? Q7:How often do you experience halos? Q8:How severe were these halos? Q9:If you CURRENTLY DRIVE: how much difficulty do you have driving at night? Q10:If you DO NOT DRIVE at night, what is the reason? Q11:How satisfied are you with your cataract surgery result? Q12:Would you recommend cataract surgery and new lenses that were put into your eyes to other people? | Full Analysis Set (FAS) | Posted | Number | percentage of subjects | Preoperative and Month 3 (Day 90-120 post second eye implantation) |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 1 |
| 45 |
| EG001 | TFNT00 First Eye | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the first eye | 0 | 45 | 0 | 45 | 23 | 45 |
| EG002 | TFNT00 Second Eye | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye | 0 | 44 | 1 | 44 | 20 | 44 |
| EG003 | TFNT00 Systemic | All subjects with attempted test article implantation (successful or aborted after contact with the eye) | 0 | 45 | 2 | 45 | 3 | 45 |
| Device dislocation | Product Issues | MedDRA (21.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Glare | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Halo vision | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
|
| +1.0 D |
|
|
| +0.5 D |
|
|
| 0.0 D |
|
|
| -0.5 D |
|
|
| -1.0 D |
|
|
| -1.5 D |
|
|
| -2.0 D |
|
|
| -2.5 D |
|
|
| -3.0 D |
|
|
| -3.5 D |
|
|
| -4.0 D |
|
|
| -4.5 D |
|
|
| -5.0 D |
|
|
|
|
| Month 3 |
|
|
|
| Month 3 |
|
|
|
| Month 3 |
|
|
|
| Title | Measurements |
|---|---|
|
| 18 cpd |
|
| Title | Measurements |
|---|---|
|
| 18 cpd |
|
| Q1: Neither satisfied nor dissatisfied |
|
| Q1: Satisfied |
|
| Q1: Very satisfied |
|
| Q2: None of the time |
|
| Q2: Some of the time |
|
| Q2: Most of the time |
|
| Q2: All of the time |
|
| Q3: Very dissatisfied |
|
| Q3: Dissatisfied |
|
| Q3: Neither satisfied nor dissatisfied |
|
| Q3: Satisfied |
|
| Q3: Very satisfied |
|
| Q4: None of the time |
|
| Q4: Some of the time |
|
| Q4: Most of the time |
|
| Q4: All of the time |
|
| Q5: Very dissatisfied |
|
| Q5: Dissatisfied |
|
| Q5: Neither satisfied nor dissatisfied |
|
| Q5: Satisfied |
|
| Q5: Very satisfied |
|
| Q6: None of the time |
|
| Q6: Some of the time |
|
| Q6: Most of the time |
|
| Q6: All of the time |
|
| Q7: None of the time |
|
| Q7: Some of the time |
|
| Q7: Most of the time |
|
| Q7: All of the time |
|
| Q8: None |
|
| Q8: Mild |
|
| Q8: Moderate |
|
| Q8: Severe |
|
| Q9: No difficulty at all |
|
| Q9: A little difficulty |
|
| Q9: Moderate difficulty |
|
| Q9: Extreme difficulty |
|
| Q9: NA : I do not drive at night |
|
| Q10: Because of your current eyesight |
|
| Q10: Because you are not interested in driving |
|
| Q10: Because you have other reasons |
|
| Q10: NA: I drive at night |
|
| Q11: Very dissatisfied |
|
| Q11: Dissatisfied |
|
| Q11: Neither satisfied nor dissatisfied |
|
| Q11: Satisfied |
|
| Q11: Very satisfied |
|
| Q12: No |
|
| Q12: Yes |
|