Trial · NCT06294847
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in visual recovery (difference between preoperative and postoperative visual acuity) at 3 months postoperative (after a successful reapplication procedure) of at least 6 letters (ETDRS scale) between the two groups (treatment and placebo) | 3 months | Difference in visual recovery (difference between preoperative and postoperative visual acuity) at 3 months postoperative (after a successful reapplication procedure) of at least 6 letters (Early Treatment Diabetic Retinopathy Study (ETDRS scale) between the two groups (treatment and placebo). The minimum and maximums valus : Minimum value is 6/95 equivalent in ETDRS letter score read at 4 m = 55. Maximum value is 6/6 equivalement in ETDRS letter score read at 4 m= 115. Higher score mean better ourcome |
| Secondary | Central Nervous Epithelium (CNE) thickness | 1, 3, and 6 months | Central Nervous Epithelium (CNE) thickness, measured by SD-OCT (Spectral-Domain Optical Coherence Tomography), within the central 1mm compared to the contralateral eye in the treated group versus the placebo group (measurement adjusted to the contralateral eye to account for interindividual variability) at 1, 3, and 6 months. |
| Secondary | Automated microperimetry at 1, 3, and 6 months: Macular sensitivity difference between the two groups. | 1, 3, and 6 months | Automated microperimetry at 1, 3, and 6 months: Macular sensitivity difference between the two groups. |
| Secondary | Contrast sensitivity measurement using the Clinic CSF2.0 application. | Day 7, Day 30, Day 60, Day 60, Day 90 and Day 180 | Contrast sensitivity measurement using the Clinic CSF2.012 application (Contrast sensitivity function 2.0 application). |
| Secondary | Presence/absence of abnormal signs on optical coherence tomography (OCT) images (cysts, folds, membrane, ellipsoid zone, external limiting membrane). | 1, 3 and 6 months | Presence/absence of abnormal signs on optical coherence tomography (OCT) images (cysts, folds, membrane, ellipsoid zone, external limiting membrane). |
| Secondary | Retinal thickness measured by OCT (retinal layers and presence of cysts, layer segmentation and measurement in the central 1 and 3 mm in ETDRS quadrants). | 1, 3 and 6 months | Retinal thickness measured by OCT (retinal layers and presence of cysts, layer segmentation and measurement in the central 1 and 3 mm in ETDRS quadrants). |
| Secondary | Number of macular cones and retinal pigment epithelium (RPE) cells measured by Adaptive Optics at 1, 3, and 6 months with the "Cellularis" device that allows visualization of cones and RPE. | 1, 3 and 6 months | Number of macular cones and retinal pigment epithelium (RPE) cells measured by Adaptive Optics at 1, 3, and 6 months with the "Cellularis" device that allows visualization of cones and RPE. |
| Secondary | Blood test: liver parameters - AST (SGOT), ALT (SGPT), PAL, and γ-GT. | Day 7 and Day 30 | Blood test: liver parameters - AST (SGOT), ALT (SGPT), PAL, and γ-GT. |
| Secondary | Evolution of the best visual acuity measured at Day 0, Day 7, Day 30, Day 60, Day 90, and Day 180: Difference between the treated and placebo groups in the progression curves of visual acuity. | Day 7 and Day 30 | Evolution of the best visual acuity measured at Day 0, Day 7, Day 30, Day 60, Day 90, and Day 180: Difference between the treated and placebo groups in the progression curves of visual acuity. |
| Secondary | Presence of metamorphopsia. | 1, 3 and 6 months | Presence of metamorphopsia. |
| Secondary | Tolerance and occurrence of adverse events. | 1, 3 and 6 months | Tolerance and occurrence of adverse events. |
| Secondary | National Eye Institute Visual Functioning Questionnaire-25 (NEIVFQ-25) quality of life questionnaire before surgery, at ±7 days postoperative, and at 3 months postoperative. | 1, 3 and 6 months | National Eye Institute Visual Functioning Questionnaire-25 (NEIVFQ-25) quality of life questionnaire before surgery, at ±7 days postoperative, and at 3 months postoperative. |
| Secondary | Correlation between protein levels, bile acids, or other molecular markers in ocular and/or blood fluids and functional and anatomical ocular parameters pre- and post-operatively at different observation times. | 1 month | Correlation between protein levels, bile acids, or other molecular markers in ocular and/or blood fluids and functional and anatomical ocular parameters pre- and post-operatively at different observation times. |
| Secondary | Correlation between the effective duration of treatment and functional and anatomical outcomes at different observation times. | 6 months | Correlation between the effective duration of treatment and functional and anatomical outcomes at different observation times. |
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/NCT06294847/registered