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Recruiting NCT06289491

A Trial of Hydrus Microstent Versus Goniotomy

No phase Interventional Glaucoma Glaucoma, Open-Angle

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydrus Microstent, Incisional goniotomy, Excisional goniotomy.
Who it may be relevant to
Registry conditions: Glaucoma, Glaucoma, Open-Angle. Basic parameters: 40 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Randomized Trial of Hydrus Microstent Versus Goniotomy

Overview

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.

Interventions

  • Procedure Hydrus Microstent
    Patients will have a Hydrus Microstent inserted into the canal of Schlemm at the time of cataract surgery
  • Procedure Incisional goniotomy
    Patients will have incisional goniotomy to open the trabecular meshwork with a Sinskey hook at the time of cataract surgery
  • Procedure Excisional goniotomy
    Patients will have excisional goniotomy to remove the trabecular meshwork with a Kahook Dual Blade at the time of cataract surgery

Primary outcome measures

  • Intraocular pressure [Time frame: 3 years]
  • Intraocular pressure-lowering medications [Time frame: 3 years]
Secondary outcome measures (1)
  • Surgical complications [Time frame: 3 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Massachusetts Eye and Ear — Boston

Identifiers

NCT: NCT06289491 · 2024P000544

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗