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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma
• Intervention / Treatment: Device: BGS goggles

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Byers Eye Institute at Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Participant must be medically able to undergo the testing required in the schedule of events (SOE).
2. Participant's clinical diagnosis must be consistent with glaucoma characterized by clinical evidence of progressive retinal ganglion cell dysfunction and degeneration using at least one visual field and at least one structural modality, OR with ocular hypertension with intraocular pressure above 21 mm Hg.
3. If a participant has two eyes meeting study criteria, both may be enrolled.
4. Subjects with orbital anatomy that permits a proper seal in both eyes when goggles are placed over eyes and can tolerate measurements with goggles in place
5. Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.

Exclusion Criteria:

1. Subjects with a history of allergy to primary study device material (i.e., silicone)
2. Subjects with a history of any ocular disorder or condition (e.g., corneal transplant) in either eye that would likely interfere with the interpretation of the study results or compromise subject safety
3. Subjects with a prior retinal detachment, active retinal detachment, an untreated retinal detachment, unresolved cystoid macular edema, or any other fundus findings that may prevent visualization of the retina in either eye; subjects with macular degeneration are not excluded from participation in the study
4. Subjects with a history of prior penetrating glaucoma surgery (e.g. trabeculectomy, tube shunt, etc.) in either eye
5. Subjects with narrow anterior chamber angle anatomy in either eye as visualized by gonioscopy with a Shaffer angle grade of ≤ 2 in any of the four quadrants
6. Subjects with eyelid edema, festoons or excessive skin laxity in either eye
7. Subjects with conjunctival chemosis in either eye
8. Subjects with best corrected visual acuity of 20/200 or worse in either eye due to glaucoma
9. Subjects who have had intraocular surgery in the study eye within 12 weeks prior to the screening visit , or who, in the opinion of the investigator, may require any ocular surgery (e.g., cataract extraction or glaucoma procedure) in either eye during the course of the study
10. Subjects who do not wish to or cannot comply with study procedures, including home use of the study device
11. Subjects with any physical or mental condition that would, in the opinion of the investigator, increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BGS use; Use of BGS goggles for a 3-6 weeks period.	Device: BGS goggles; BGS goggles use for 3-6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): March 28, 2022

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 20, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular Hypertension
• Other Study ID Numbers: 50800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No