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NCT02687581 · ClinicalTrials.gov registry record · NA
Efficacy of Intermittent Occlusion Therapy Glasses for Amblyopia
A NA study, sponsored by Salus University.
- Terminated
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT02687581: Clinical Trial NA study, sponsored by Salus University.
NCT02687581 is a NA study that was terminated before completion, run by Salus University. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02687581, a NA study, was terminated before completion, sponsored by Salus University.
- TERMINATED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study Summary
This study is designed to evaluate the effectiveness of a novel amblyopia treatment - Intermittent occlusion therapy (IO-therapy) glasses (AmblyzTM) in treating severe amblyopia. Children ages 3 to 8 years with severe amblyopia (visual acuity of 20/100 to 20/400 in the amblyopic eye) will be enrolled and randomized into two groups: 1) standard 6-hour patching group or 2) 12-hour IO-therapy glasses group. The study also observe the effectiveness of IO-therapy glasses on two types of difficult amblyopia: deprivation amblyopia associated with congenital or developmental cataract, and myopic anisometropic amblyopia.
Primary Outcome
Visual acuity was measured with ATS-HOTV methods in logMAR. The larger amount means the worse acuity. Visual acuity improvement is defined as the change at the primary outcome follow-up visit from the baseline. (Note: Visual acuity improvement = Visual acuity at the baseline - Visual acuity at the 12-week follow-up) The larger amount of change indicates better improvement.
Interventions
- DEVICE IO-therapy Glasses
- DEVICE patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2016-12-19 |
| Est. Completion | 2021-05-30 |
| Phase | NA |
Why NCT02687581 stopped before completion
NCT02687581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which IO-therapy Glasses is the first listed.
NCT02687581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02687581 about?
NCT02687581 is a clinical study titled "Efficacy of Intermittent Occlusion Therapy Glasses for Amblyopia". This study is designed to evaluate the effectiveness of a novel amblyopia treatment - Intermittent occlusion therapy (IO-therapy) glasses (AmblyzTM) in treating severe amblyopia. Children ages 3 to 8 years with severe amblyopia (visual acuity of 20/100 to 20/400 in the amblyopic eye) will be enroll...
What is the current status of trial NCT02687581?
This trial is currently terminated. It is a NA study. The enrollment target is 18 participants. The study started on 2016-12-19. Estimated completion is 2021-05-30.
What interventions are being tested in trial NCT02687581?
The interventions under investigation include: IO-therapy Glasses (DEVICE), patch (DEVICE).
Who is sponsoring clinical trial NCT02687581?
This trial is sponsored by Salus University, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02687581's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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