A Trial of Hydrus Microstent Versus Goniotomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorMassachusetts Eye and Ear Infirmary
About this trial
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 criteria
Qualifiers
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 point <15 dB
Disqualifiers
Prior argon laser trabeculoplasty, laser peripheral iridotomy, incisional glaucoma surgery, or cyclophotocoagulation
Selective laser trabeculoplasty within 90 days of study enrollment
Iridotrabecular contact for 180 degrees or greater
Peripheral anterior synechiae in nasal or inferior angle
Trial design
Treatments tested in this trial
- Hydrus Microstent
- Incisional goniotomy
- Excisional goniotomy
Treatment groups
243 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov