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NCT01973348 · ClinicalTrials.gov registry record · NA
Comparison of AmblyzTM Glasses and Patching for Amblyopia
A NA study, sponsored by Indiana University.
- Terminated
- Registry status
- NA
- Development phase
- 45
- Enrollment target
NCT01973348: Clinical Trial NA study, sponsored by Indiana University.
NCT01973348 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 45 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01973348, a NA study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
Study Summary
Electronic eyeglasses, Amblyz™glasses, are a new medical device designed to treat amblyopia, which intermittently become opaque and provide effective occlusion for 50% of the time they are worn. A non-randomized study reported that Amblyz glasses yield an improvement in the amblyopic eye and offer an alternative effective treatment. We are unaware of any randomized clinical trial reports of response to AmblyzTM glasses treatment of amblyopia. Our hypothesis: Amblyz™glasses can improve visual acuity of the amblyopic eye as effective as traditional patching treatment. The primary objective is to determine if AmblyzTM equally treats moderate amblyopia as the standard 2-hour patching treatment and AmblyzTM equally treats severe amblyopia as the standard 6-hour patching treatment. This study is designed to evaluate the effectiveness of a novel amblyopia treatment, AmblyzTM glasses, in treating amblyopia. Moderate amblyopia: Children ages 3 to \<8 years with visual acuity of 20/40 to 20/80 in the amblyopic eye will be enrolled and randomized into two groups: 4-hour AmblyzTM glasses treatment group and standard 2-hour patching control group. Severe amblyopia: Children ages 3 to \<8 years with visual acuity of 20/100 to 20/400 in the amblyopic eye will be enrolled and randomized into two groups: 12-hour AmblyzTM glasses treatment group and standard 6-hour patching control group.
Primary Outcome
Visual acuity change during 12 weeks: the difference of visual acuity at baseline and 12 weeks.
Interventions
- DEVICE 4-hour AmblyZ glasses
- DEVICE 12-hour AmblyZ glasses
- DEVICE 2-hour patching
- DEVICE 6-hour patching
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2013-11 |
| Est. Completion | 2016-05 |
| Phase | NA |
Why NCT01973348 stopped before completion
NCT01973348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 4 interventions - of which 4-hour AmblyZ glasses is the first listed.
NCT01973348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01973348 about?
NCT01973348 is a clinical study titled "Comparison of AmblyzTM Glasses and Patching for Amblyopia". Electronic eyeglasses, Amblyz™glasses, are a new medical device designed to treat amblyopia, which intermittently become opaque and provide effective occlusion for 50% of the time they are worn. A non-randomized study reported that Amblyz glasses yield an improvement in the amblyopic eye and offer a...
What is the current status of trial NCT01973348?
This trial is currently terminated. It is a NA study. The enrollment target is 45 participants. The study started on 2013-11. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01973348?
The interventions under investigation include: 4-hour AmblyZ glasses (DEVICE), 12-hour AmblyZ glasses (DEVICE), 2-hour patching (DEVICE), 6-hour patching (DEVICE).
Who is sponsoring clinical trial NCT01973348?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01973348's enrollment target sits among peer trials
45 1411th of 2000 higher than 578 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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