Trial · NCT03507686
Outcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 42
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Best-Corrected Visual Acuity (BCVA) as Measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) Chart in Letters at Month 12 | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. | letters | MEAN |
| PRIMARY | Ophthalmic Examination Assessment: Mean Intraocular Pressure (IOP) at Month 12 | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. | mmHg | MEAN |
| PRIMARY | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Baseline, Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified category at specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Baseline, Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified category at specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified category of specified parameter. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Spectral Domain Optical Coherence Tomography (SD-OCT): Foveal Subfield Thickness at Month 12 | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. | microns (µ) | MEAN |
| PRIMARY | SD-OCT: Total Macular Volume at Month 12 | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye. | cubic millimeters (mm^3) | MEAN |
| PRIMARY | SD-OCT: Central Horizontal Ellipsoid Width at Month 12 | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye. | microns (μ) | MEAN |
| PRIMARY | SD-OCT: Central Ellipsoid Area at Month 12 | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye. | square millimeters (mm^2) | MEAN |
| PRIMARY | SD-OCT: Square Root of Central Ellipsoid Area at Month 12 | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye. | mm | MEAN |
| PRIMARY | SD-OCT: Choroidal Thickness at Foveal Center at Month 12 | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. | microns (μ) | MEAN |
| PRIMARY | Fundus Autofluorescence (AF): Mean Total Area of Preserved Autofluorescence at Month 12 | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified parameter. | mm^2 | MEAN |
| PRIMARY | AF: Mean Square Root of Total Area of Preserved AF at Month 12 | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye. | mm | MEAN |
| PRIMARY | AF: Mean Distance From Foveal Center to Nearest Border of Preserved AF at Month 12 | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye. | mm | MEAN |
| PRIMARY | Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Microperimetry: Retinal Mean Sensitivity at Month 12 | Month 12 | All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. | decibels (dB) | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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