A Trial of Hydrus Microstent Versus Goniotomy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT06289491
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 14, 2025
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2029

Study Design

Enrollment
243 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hydrus Microstent
  • Experimental: Incisional goniotomy
  • Experimental: Excisional goniotomy

Primary Outcome Measure

Intraocular pressure [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Eye and EarBostonMassachusetts02114
Michael Lin, MD
[email protected]
617-573-3707
Michael Lin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Glaucoma
By specialty
Ophthalmology
By research site
Massachusetts Eye and Ear· Boston, MA

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