Trial · NCT03507686
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 42
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | BCVA was assessed for both eyes using the ETDRS visual acuity (VA) chart. BCVA test should be performed prior to pupil dilation, and distance refraction should be carried out before BCVA is measured. Initially, letters are read at a distance of 4 meters from the chart. If \<20 letters are read at 4 meters, testing at 1 meter should be performed. BCVA is reported as number of letters read correctly by the participant using the ETDRS Scale (ranging from 0 to 100 letters) in the study eyes. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. |
| Primary | Ophthalmic Examination Assessment: Mean Intraocular Pressure (IOP) at Month 12 | Month 12 | IOP, the fluid pressure inside the eye was measured and reported in millimeters mercury (mmHg). |
| Primary | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Baseline, Month 12 | Slit lamp examinations of study eyes included examination of Cornea, Conjunctiva, Iris, Lens, and Anterior Segment. |
| Primary | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Baseline, Month 12 | Dilated Ophthalmoscopy examination of study eyes included examination of Vitreous, Macula, Peripheral retina, Choroid, and Optic nerve. |
| Primary | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Month 12 | The following lens opacity grades are reported for categories 1-4: Nuclear Opalescence grade, Nuclear Color grade, Cortical Cataract grade, and Posterior Cataract grade. Opacification severity is graded on a decimal scale, scores can range from 0.1 (no opacity) to 6.9 (maximum opacity) for the Nuclear Opalescence and Nuclear Color grades; and scores can range from 0.1 (lens clear) to 5.9 (lens unclear) for the Cortical and Posterior Cataract grades. Category 1 includes values 1, 1.0 and 0.x, Category 2 includes values 2, 2.0 and 1.x, Category 3 includes values 3, 3.0 and 2.x, and Category 4 includes values 4, 4.0, 3.x and any values above 4. For each opacification type the higher grading scores indicate greater severity. |
| Primary | Spectral Domain Optical Coherence Tomography (SD-OCT): Foveal Subfield Thickness at Month 12 | Month 12 | SD-OCT was used to assess change in foveal subfield thickness. The measurements were taken after dilation of the participant's pupil. |
| Primary | SD-OCT: Total Macular Volume at Month 12 | Month 12 | SD-OCT was used to assess change in total macular volume. The measurements were taken after dilation of the participant's pupil. |
| Primary | SD-OCT: Central Horizontal Ellipsoid Width at Month 12 | Month 12 | SD-OCT was used to assess change in central horizontal ellipsoid width. The measurements were taken after dilation of the participant's pupil. |
| Primary | SD-OCT: Central Ellipsoid Area at Month 12 | Month 12 | SD-OCT was used to assess change in central ellipsoid area. The measurements were taken after dilation of the participant's pupil. |
| Primary | SD-OCT: Square Root of Central Ellipsoid Area at Month 12 | Month 12 | SD-OCT was used to assess change in square root of central ellipsoid area. The measurements were taken after dilation of the participant's pupil. |
| Primary | SD-OCT: Choroidal Thickness at Foveal Center at Month 12 | Month 12 | SD-OCT was used to assess change in choroidal thickness. The measurements were taken after dilation of the participant's pupil. |
| Primary | Fundus Autofluorescence (AF): Mean Total Area of Preserved Autofluorescence at Month 12 | Month 12 | Fundus AF was used to assess the total area of preserved AF. Areas of preserved AF were identified as well-demarcated regions of relative hyper autofluorescence (hyper AF) compared with the background areas of surrounding atrophy. |
| Primary | AF: Mean Square Root of Total Area of Preserved AF at Month 12 | Month 12 | Fundus AF was used to assess the square root of total area of preserved AF. Areas of preserved AF were identified as well-demarcated regions of relative hyper AF compared with the background areas of surrounding atrophy. |
| Primary | AF: Mean Distance From Foveal Center to Nearest Border of Preserved AF at Month 12 | Month 12 | Fundus AF was used to assess the distance from foveal center to nearest border of preserved AF. |
| Primary | Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity | Month 12 | Number of participants with RPE hyperplasia are reported for severity grades: mild, moderate, severe. |
| Primary | Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity | Month 12 | Number of participants with retinal arteriolar narrowing are reported for severity grades: mild, moderate, severe. |
| Primary | Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity | Month 12 | Number of participants with retinal vessel sheathing are reported for severity grades: mild, moderate, severe. |
| Primary | Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity | Month 12 | Number of participants with optic atrophy/pallor are reported for severity grades: mild, moderate, severe. |
| Primary | Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity | Month 12 | Number of participants with optic disc swelling are reported for severity grades: mild, moderate, severe. |
| Primary | Microperimetry: Retinal Mean Sensitivity at Month 12 | Month 12 | Microperimetry was conducted to assess retinal mean sensitivity within the macula. Retinal mean sensitivity to light was measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers (decibels) indicate higher retinal sensitivity. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03507686/registered