NCT04035239

Retinal Effects of Balance Goggles System in Glaucoma Balance Goggles System (BGS) in Patients With Glaucoma

An Open-Label Phase Ib Study to Evaluate Retinal Imaging After Short-term Use of the Balance Goggles System (BGS) in Patients With Glaucoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DEVICE	BGS goggles	BGS goggles use for 3-6 weeks

Timeline

• Start date: 2019-07-23
• Primary completion: 2020-02-28
• Completion: 2022-03-28
• First posted: 2019-07-29
• Last updated: 2022-11-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study