Health TrialsbyHealthPanel

A Trial of Hydrus Microstent Versus Goniotomy

ConditionsGlaucomaGlaucoma, Open-Angle
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorMassachusetts Eye and Ear Infirmary

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hydrus Microstent

    Procedure/Surgery

    Patients will have a Hydrus Microstent inserted into the canal of Schlemm at the time of cataract surgery

  • Incisional goniotomy

    Procedure/Surgery

    Patients will have incisional goniotomy to open the trabecular meshwork with a Sinskey hook at the time of cataract surgery

  • Excisional goniotomy

    Procedure/Surgery

    Patients will have excisional goniotomy to remove the trabecular meshwork with a Kahook Dual Blade at the time of cataract surgery

Treatment groups

243 Participants
are divided into 3 treatment groups
Group A: Hydrus MicrostentExperimental treatment 1 intervention
Group B: Incisional goniotomyExperimental treatment 1 intervention
Group C: Excisional goniotomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intraocular pressure

Time frame
3 years
2

Intraocular pressure-lowering medications

Time frame
3 years

Secondary outcomes

1

Surgical complications

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts Eye and Ear Infirmary

Lead sponsor

Source ClinicalTrials.gov
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