Status:
COMPLETED
Retinal Effects of Balance Goggles System in Glaucoma Balance Goggles System (BGS) in Patients With Glaucoma
Lead Sponsor:
Stanford University
Conditions:
Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 G...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04035239
Start Date
July 23 2019
End Date
March 28 2022
Last Update
November 23 2022
Active Locations (1)
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1
Byers Eye Institute at Stanford University
Palo Alto, California, United States, 94303