Comparing Hydrus Microstent and Goniotomy for Glaucoma Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of the Hydrus Microstent compared to incisional and excisional goniotomy when performed alongside cataract surgery in patients with mild to moderate open-angle glaucoma. Participants will be randomly assigned to one of the three surgical interventions to assess how well they lower intraocular pressure and their respective safety profiles. The study aims to provide insights into the best surgical options for managing glaucoma in conjunction with cataract surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts Eye and Ear
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Michael M Lin, MD
• Email: michael_lin@meei.harvard.edu
• Phone: 617-573-3707

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.