Hydrus Microstent and Lens Extraction for the Treatment of Primary Angle-Closure Glaucoma

Exclusion Criteria

• •1. Pseudophakia in the intended study eye
• •2. All forms of glaucoma other than primary angle-closure (i.e. all open-angle glaucoma including primary open-angle, pseudoexfoliative, or pigmentary glaucoma; neovascular, uveitic, traumatic, steroid induced, lens induced, or glaucoma associated with increased episcleral venous pressure; congenital or developmental glaucoma).
• •3. Secondary angle-closure glaucoma
• •4. Advanced glaucoma, defined as visual field mean deviation worse than -15 dB, or cup-to-disc ration \> or = 0.9.
• •5. Visual field depression within the central 5 degrees of fixation, on pattern deviation probability plot.
• •6. Eyes with an anticipated need for incisional glaucoma surgery (e.g. trabeculectomy or tube shunt) within the 12-month follow-up period.
• •7. Central corneal thickness \>620 or \<490 microns.
• •8. Axial length \< or = 19 mm (nanophthalmos).
• •9. Previous incisional glaucoma surgery in the study eye, including trabeculectomy, tube shunt, and non-penetrating procedures such as deep sclerectomy, viscocanalostomy or canaloplasty.
• •10. Plateau iris syndrome.
• •11. History of complicated intraocular surgery.
• •12. Previous MIGS surgery in the study eye.
• •13. Proliferative diabetic retinopathy.
• •14. Previous surgery for retinal detachment.
• •15. Clinically significant corneal dystrophy (e.g. Fuch's Dystrophy).
• •16. Best-corrected visual acuity in the fellow eye worse than 20/200.
• •17. Previous corneal surgery.
• •18. Previous refractive surgery.
• •19. Degenerative visual disorders such as exudative age-related macular degeneration.
• •20. Clinically significant ocular inflammation or infection within thirty days prior to screening.
• •21. 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.
• •22. Pregnant or nursing females.