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NCT04035239 · ClinicalTrials.gov registry record · Phase 1
Retinal Effects of Balance Goggles System in Glaucoma Balance Goggles System (BGS) in Patients With Glaucoma
A Phase 1 study of Glaucoma and Ocular Hypertension, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT04035239: Completed Phase 1 study of Glaucoma and Ocular Hypertension, sponsored by Stanford University.
NCT04035239 is a Phase 1 study of Glaucoma and Ocular Hypertension that has completed, run by Stanford University. The registered enrollment target is 11 participants, below the 911-participant average among 92 other Glaucoma trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04035239, a Phase 1 study of Glaucoma and Ocular Hypertension, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label trial of 20 study participants with glaucoma or ocular hypertension. Participants with qualifying study eye(s) after screening and baseline evaluations will receive the Balance Goggles System. After a baseline evaluation (prior to negative pressure application through the BGS), study eyes will be treated for one hour in the clinic and be evaluated again. They will then use the BGS for the next 3-6 weeks and be evaluated again. The goal is to determine whether the intraocular pressure (IOP)-lowering effects of BGS is accompanied by changes in retinal thickness measured by optical coherence tomography (OCT), retinal vascular density measured by OCT-angiography, or retinal fluorescence measured by a fundus camera.
Primary Outcome
Change from baseline in retinal nerve fiber layer thickness measured by optical coherence tomography imaging
Conditions Studied
Interventions
- DEVICE BGS goggles
Study Locations (1)
California
- Byers Eye Institute at Stanford University - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-07-23 |
| Est. Completion | 2022-03-28 |
| Phase | Phase 1 |
What the finished NCT04035239 record still lists
NCT04035239 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 911-participant average among 92 other Glaucoma trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Glaucoma appearing as the primary indexed condition, and to 1 intervention - of which BGS goggles is the first listed.
NCT04035239 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04035239 about?
NCT04035239 is a clinical study titled "Retinal Effects of Balance Goggles System in Glaucoma Balance Goggles System (BGS) in Patients With Glaucoma". This is an open-label trial of 20 study participants with glaucoma or ocular hypertension. Participants with qualifying study eye(s) after screening and baseline evaluations will receive the Balance Goggles System. After a baseline evaluation (prior to negative pressure application through the BGS),...
What is the current status of trial NCT04035239?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2019-07-23. Estimated completion is 2022-03-28.
What conditions does trial NCT04035239 study?
This clinical trial studies the following conditions: Glaucoma, Ocular Hypertension.
What interventions are being tested in trial NCT04035239?
The interventions under investigation include: BGS goggles (DEVICE).
Who is sponsoring clinical trial NCT04035239?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04035239 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04035239's enrollment target sits among peer trials
11 90th of 92 higher than 2 of 92 other Glaucoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glaucoma 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.
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