A Trial Of Hydrus Microstent Versus Goniotomy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 26-003187
NCT ID: NCT06289491
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 03/23/2026. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Tyler Kaplan, M.D. |
Open for enrollment |
|
More information
Publications
Publications are currently not available