Randomized Trial of Hydrus Microstent Versus Goniotomy

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Massachusetts Eye and Ear
RECRUITING
Boston
Contact Information
Primary
Michael M Lin, MD
michael_lin@meei.harvard.edu
617-936-6082
Time Frame
Start Date: 2025-02-14
Estimated Completion Date: 2029-04
Participants
Target number of participants: 243
Treatments
Experimental: Hydrus Microstent
Experimental: Incisional goniotomy
Experimental: Excisional goniotomy
Sponsors
Leads: Massachusetts Eye and Ear Infirmary

This content was sourced from clinicaltrials.gov