A Trial of Hydrus Microstent Versus Goniotomy

Launched by MASSACHUSETTS EYE AND EAR INFIRMARY · Feb 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at three different surgical options to help lower eye pressure in patients with mild to moderate open-angle glaucoma who also need cataract surgery. The surgeries being compared are the Hydrus Microstent, incisional goniotomy, and excisional goniotomy. The main goals of the study are to find out how effectively these surgeries lower eye pressure and to see which one has the safest outcomes.

To participate in the trial, individuals should have a cataract that needs surgery and mild to moderate open-angle glaucoma. They will be randomly assigned to one of the three surgery groups. Participants will need to attend follow-up appointments after the surgery to monitor their recovery. It’s important for potential participants to understand the eligibility requirements and to be willing to provide informed consent before joining the trial. If you or someone you know is considering this trial, it could be a valuable opportunity to help improve glaucoma treatment options.

Gender

ALL

Eligibility criteria

• 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 point \<15 dB
• • Medicated IOP between 10 to 31 mm Hg, inclusive, at time of decision for surgery
• • Willing and able to understand and provide informed consent
• • Willing and able to attend postoperative examinations per protocol schedule
• Exclusion Criteria:
• • 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
• • Best corrected visual acuity worse than 20/200
• • Phacodonesis on pre-operative examination
• • Vitreous in anterior chamber on pre-operative examination
• • Nanophthalmos
• • Anti-platelet and anticoagulant medications other than aspirin 81mg daily
• • Active treatment for another ophthalmic condition in either eye (e.g., anti-VEGF injections, steroids for corneal transplant)
• • Abnormality in study eye that could affect tonometry
• • Glaucoma diagnosis other than the above
• • Normal tension glaucoma
• • Conditions that can cause elevated episcleral venous pressure (e.g., Sturge-Weber syndrome, Graves disease, retrobulbar tumor)
• • History of uveitis in either eye
• • Inability to complete gonioscopy examination
• • Use of oral steroids within 90 days or anticipated use of oral steroids
• • Oral medications that can affect IOP, including oral carbonic anhydrase inhibitors such as acetazolamide and methazolamide
• • History of steroid-associated IOP elevation
• • Medically unfit for attending planned study visits
• • Involvement in another interventional research study