GORE Glaucoma Drainage Implant Clinical Study Dominican Republic

Inclusion Criteria:

• Males and females, age 18 to 85 years, inclusive at screening visit

• A diagnosis of primary open-angle glaucoma (Shaffer angle ≥ 3 as seen on gonioscopy)at screening visit

• Medicated intraocular pressure at screening visit and the mean medicated diurnal IOPat baseline visit ≥ 18 mmHg and ≤ 40 mmHg by Goldmann Applanation Tonometry

Exclusion Criteria:

• Expected inability to implant the study device in the superotemporal quadrant (e.g.,a lack of freely mobile conjunctiva to cover the entire implanted device in thesuperotemporal quadrant)

• Diagnosis of any active ocular disease or disorder (other than glaucoma) thatrequires treatment, where the disease or treatment could be reasonably expected toaffect the vision or IOP during the duration of the study

• Prior corneal transplant surgery (full or partial thickness transplants) orclinically significant corneal dystrophy, e.g., Fuchs' dystrophy (> 12 confluentguttae) in the study eye

• Concurrent cataract surgery or anticipated need for cataract surgery (i.e.,clinically significant cataract) in the study eye during the 12 months followingimplantation

• BCDVA worse than 20/200 in the fellow (non-study) eye at the screening visit andBCDVA of the fellow eye cannot be worse than that of the study eye.