NCT06289491

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Feb 2025Apr 2029

First Submitted

Initial submission to the registry

February 25, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
12 months until next milestone

Study Start

First participant enrolled

February 14, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

February 25, 2024

Last Update Submit

March 24, 2026

Conditions

GlaucomaGlaucoma, Open-Angle

Keywords

Incisional goniotomyExcisional goniotomyHydrus MicrostentGoniotomy

Outcome Measures

Primary Outcomes (2)

  • Intraocular pressure

    3 years

  • Intraocular pressure-lowering medications

    3 years

Secondary Outcomes (1)

  • Surgical complications

    3 years

Study Arms (3)

Hydrus Microstent

EXPERIMENTAL
Procedure: Hydrus Microstent

Incisional goniotomy

EXPERIMENTAL
Procedure: Incisional goniotomy

Excisional goniotomy

EXPERIMENTAL
Procedure: Excisional goniotomy

Interventions

Hydrus MicrostentPROCEDURE

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

Hydrus Microstent
Incisional goniotomyPROCEDURE

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

Incisional goniotomy
Excisional goniotomyPROCEDURE

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

Excisional goniotomy

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Central Study Contacts

Michael M Lin, MD

CONTACT

617-573-3707michael_lin@meei.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Ophthalmology

Study Record Dates

First Submitted

February 25, 2024

First Posted

March 4, 2024

Study Start

February 14, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2029

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)