Glaucoma Laser Assessment of Stability and Sustainability

Korábbi kezelés

• Use of oral or ocular hypotensive medication for glaucoma.
• Prior history of ocular surgery except for cataract surgery (must be ≥ 2 years prior)
• Clinically significant ocular inflammation or infection within 6 months prior to screening.
• Previous corneal transplant or clinically significant corneal dystrophy, e.g., Fuch's dystrophy (≥12 confluent guttae)
• Current participation in another investigational drug or device clinical trial (which includes the fellow eye) within the past 30 calendar days.
• Pregnant or nursing women; or women of childbearing age not using medically acceptable contraceptives.
  • Accepted prior ocular procedures:

Más betegség

• Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's health at risk and/or prevent the subject from completing all study visits.

Életkor

• Clinically significant ocular pathology, other than cataract and glaucoma, including but not limited to neovascular age-related macular degeneration, advanced dry macular degeneration, and proliferative diabetic retinopathy, etc.
• Cataract surgery (if ≥ 2 years or screening)

Egyéb

• Unable to view scleral spur inferiorly with gonioscopy.
• Congenital or developmental glaucoma, angle closure glaucoma, secondary glaucoma (e.g. exfoliative, pigmentary, etc.) pigmentary, neovascular glaucoma, closed angle glaucoma, or uveitic glaucoma.
• Unclear ocular media prevent visualization of the fundus or anterior chamber angle.
• YAG capsulotomy (if ≥ 60 days of screening)

• Male and female patients aged 40 years or older
• A bilateral diagnosis of ocular hypertension, glaucoma suspect, or mild primary open angle glaucoma as defined by AAO PPP
• Treatment naïve with an unmedicated IOP between 21-35 mmHg, inclusive, and within +/- 3mmHg of each eye to be eligible
• BCVA of 20/50 or better
• The subject is able to read and understand the requirements of the study and provide written informed consent.
• The subject is willing to follow study instructions, agrees to comply with all study procedures and attend all scheduled follow-up exams for 12 months after the initial treatment.