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Retinal Effects of Balance Goggles System in Glaucoma Balance Goggles System (BGS) in Patients With Glaucoma
NCT04035239 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04035239
The ClinicalTrials.gov registry entry for NCT04035239 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,643 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04035239 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04035239?
The interventions under investigation include: BGS goggles (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04035239?
This trial is sponsored by Stanford University, which has 1,643 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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