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

Primary Purpose

Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BGS goggles

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participant must be medically able to undergo the testing required in the schedule of events (SOE).
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.
If a participant has two eyes meeting study criteria, both may be enrolled.
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
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:

Subjects with a history of allergy to primary study device material (i.e., silicone)
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
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
Subjects with a history of prior penetrating glaucoma surgery (e.g. trabeculectomy, tube shunt, etc.) in either eye
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
Subjects with eyelid edema, festoons or excessive skin laxity in either eye
Subjects with conjunctival chemosis in either eye
Subjects with best corrected visual acuity of 20/200 or worse in either eye due to glaucoma
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
Subjects who do not wish to or cannot comply with study procedures, including home use of the study device
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

Sites / Locations

Byers Eye Institute at Stanford University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BGS use

Arm Description

Use of BGS goggles for a 3-6 weeks period.

Outcomes

Primary Outcome Measures

Retinal thickness

Change from baseline in retinal nerve fiber layer thickness measured by optical coherence tomography imaging

Retinal vascular density

Change from baseline in vessel density measured by optical coherence tomographic angiography imaging

Retinal fluorescence

Change from baseline in flavoprotein fluorescence measured by fundus photography imaging

Secondary Outcome Measures

Full Information

NCT ID

NCT04035239

First Posted

July 23, 2019

Last Updated

November 20, 2022

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT04035239

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

July 23, 2019 (Actual)

Primary Completion Date

February 28, 2020 (Actual)

Study Completion Date

March 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BGS use

Arm Type

Experimental

Arm Description

Use of BGS goggles for a 3-6 weeks period.

Intervention Type

Device

Intervention Name(s)

BGS goggles

Intervention Description

BGS goggles use for 3-6 weeks

Primary Outcome Measure Information:

Title

Retinal thickness

Description

Change from baseline in retinal nerve fiber layer thickness measured by optical coherence tomography imaging

Time Frame

Over a 3-6 week treatment period to study completion

Title

Retinal vascular density

Description

Change from baseline in vessel density measured by optical coherence tomographic angiography imaging

Time Frame

Over a 3-6 week treatment period to study completion

Title

Retinal fluorescence

Description

Change from baseline in flavoprotein fluorescence measured by fundus photography imaging

Time Frame

Over a 3-6 week treatment period to study completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant must be medically able to undergo the testing required in the schedule of events (SOE). 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. If a participant has two eyes meeting study criteria, both may be enrolled. 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 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: Subjects with a history of allergy to primary study device material (i.e., silicone) 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 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 Subjects with a history of prior penetrating glaucoma surgery (e.g. trabeculectomy, tube shunt, etc.) in either eye 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 Subjects with eyelid edema, festoons or excessive skin laxity in either eye Subjects with conjunctival chemosis in either eye Subjects with best corrected visual acuity of 20/200 or worse in either eye due to glaucoma 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 Subjects who do not wish to or cannot comply with study procedures, including home use of the study device 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

Facility Information:

Facility Name

Byers Eye Institute at Stanford University

City

Palo Alto

State/Province

California

ZIP/Postal Code

94303

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35696700

Citation

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.

Results Reference

result

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

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