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

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