Trial · NCT07226141
Valproate for the Treatment of Residual Amblyopia
NCT07226141, Phase 1, Phase 2, Recruiting, Boston Children's Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Valproate for the Treatment of Residual Amblyopia. Trials, record NCT07226141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07226141
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Valproate for the Treatment of Residual Amblyopia
- NCT number
- NCT07226141
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 28 participants, estimated
- Lead sponsor
- Boston Children's Hospital
- Conditions
- Amblyopia, Amblyopia Unilateral, Amblyopia, Anisometropic, Amblyopia Strabismic
- Interventions
- Valproate, Placebo, Patch
- First posted
- 2025-11-10
- Last updated
- 2026-07-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Amblyopic Eye Best-Corrected Visual Acuity (BCVA) | The comparison will be made between the randomized groups at the 8-week visit, prior to cross-over. | Change in visual acuity of the amblyopic eye after 8 weeks of treatment with valproate plus patching versus placebo plus patching. |
| Secondary | Proportion of patients with resolved amblyopia | 8 weeks | Proportion of participants achieving resolution of amblyopia, defined as visual acuity in the amblyopic eye of 20/25 or better, following 8 weeks of treatment. |
| Secondary | Durability of amblyopic eye visual acuity response | 8 weeks | Among those in the study arm receiving valproate followed by placebo, the visual acuity in the amblyopic eye will be compared between the 8 week visit (when valproate is discontinued) to the 16 week visit (after completion of placebo). This difference reflects the maintenance of visual acuity and will be analyzed and interpreted in the context of change at an individual level in response to valproate between weeks 0 and 8. The proportion of subjects from the valproate then placebo group maintaining a ≥ 10 letters (2 lines) improvement in the amblyopic eye visual acuity will be calculated and a 95% confidence interval on overall change will be computed. |
| Secondary | Change in stereoacuity | 8 weeks and 16 weeks | Change in log arcsec in stereoacuity assessed with the Randot Preschool Stereoacuity Test. The change in log arcseconds will be compared between groups. Aggregated results will inform how overall stereoacuity has changed, and the difference from baseline will be compared across treatment groups and timepoints. |
| Secondary | Quality of life measures using the Pediatric Eye Questionnaire (PedEyeQ) | Change from baseline at 8 weeks and 16 weeks. | This measure assesses the quality of life deficits across four domains: functional vision, bothered by eyes/vision, social, and frustration/worry. It uses a 3-point frequency scale and Rasch-calibrated domain scores (0-100). |
| Secondary | Tolerability and Safety of Valproate | Assessed throughout the study duration at 1,2, 4, 6, 8, 9, 10, 12, 14 and 16 weeks. | This measure evaluates the tolerability and safety of valproate, assessing the proportion of patients reporting mild, moderate, and severe adverse events, and comparing the proportion of participants requiring dose tapering or de-escalation. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers54
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07226141
GET https://conductscience.org/api/trials/v1/NCT07226141/papers?page=2