Randomized Trial of Hydrus Microstent Versus Goniotomy
Massachusetts Eye and Ear Infirmary
Summary
The goal of this clinical trial is to evaluate the comparative efficacy and safety of Hydrus Microstent, incisional goniotomy, and excisional goniotomy when combined with cataract surgery in patients with mild and moderate open-angle glaucoma. The main questions it aims to answer are: * How do the intraocular pressure lowering effects of these three microinvasive glaucoma surgeries compare? * How do the safety profiles of these three microinvasive glaucoma surgeries compare? Participants will be randomized to one of these three microinvasive glaucoma surgeries in combination with cataract surgery.
Eligibility
- Age range
- 40–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Visually significant cataract planned for surgery * Mild to moderate open-angle glaucoma, including pigmentary glaucoma and pseudoexfoliation glaucoma * Mild stage glaucoma includes glaucomatous optic neuropathy and visual field mean deviation better than -6.0 dB, with no points in the central 5 degrees \<15 dB * Moderate stage glaucoma includes: 1) glaucomatous optic neuropathy and visual field mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dB and no central 5 degree points \<15 dB or 2) mean deviation -12.0 dB or better with 1 central 5 degree po…
Interventions
- ProcedureHydrus Microstent
Patients will have a Hydrus Microstent inserted into the canal of Schlemm at the time of cataract surgery
- ProcedureIncisional goniotomy
Patients will have incisional goniotomy to open the trabecular meshwork with a Sinskey hook at the time of cataract surgery
- ProcedureExcisional goniotomy
Patients will have excisional goniotomy to remove the trabecular meshwork with a Kahook Dual Blade at the time of cataract surgery
Location
- Massachusetts Eye and EarBoston, Massachusetts