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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGS use | Experimental | Use of BGS goggles for a 3-6 weeks period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGS goggles | Device | BGS goggles use for 3-6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retinal thickness | Change from baseline in retinal nerve fiber layer thickness measured by optical coherence tomography imaging | Over a 3-6 week treatment period to study completion |
| Retinal vascular density | Change from baseline in vessel density measured by optical coherence tomographic angiography imaging | Over a 3-6 week treatment period to study completion |
| Retinal fluorescence | Change from baseline in flavoprotein fluorescence measured by fundus photography imaging | Over a 3-6 week treatment period to study completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute at Stanford University | Palo Alto | California | 94303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35696700 | Result | Sun MT, Beykin G, Lee WS, Sun Y, Chang R, Nunez M, Li KZ, Knasel C, Rich C, Goldberg JL. Structural and Metabolic Imaging After Short-term Use of the Balance Goggles System in Glaucoma Patients: A Pilot Study. J Glaucoma. 2022 Aug 1;31(8):634-638. doi: 10.1097/IJG.0000000000002066. Epub 2022 Jun 13. |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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