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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 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 45 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01973348
The ClinicalTrials.gov registry entry for NCT01973348 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which 4-hour AmblyZ glasses is the first listed.
NCT01973348 reports 0 study locations.
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.
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