Comparison of Goniotomy Device Outcomes in Combined Phacoemulsification-goniotomy Surgeries

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT07418853
Status
Not Yet Recruiting

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Conditions

  • Open Angle Glaucoma (OAG)
  • Primary Open Angle Glaucoma (POAG)
  • Secondary Open Angle Glaucoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Goniotomy — PROCEDURE
    Goniotomy opens the trabecular meshwork to lower intraocular pressure.

Study Details

The goal of this study is to determine of one of three different devices to perform goniotomy to treat glaucoma at the time of cataract surgery is more or less effective than the others. The primary outcomes are to compare intraocular pressure control and glaucoma medication use up to 6 months after surgery. Participants will under combined cataract surgery and goniotomy. They will have post-operative follow up visits at 1 day, 1 week, 1 month, 3 months, and 6 month

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

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

Arms

  • Active Comparator: SION
    Goniotomy performed with SION
  • Active Comparator: BANG
    Goniotomy performed with bent needle
  • Active Comparator: Tanito
    Goniotomy performed with Tanito hook

Primary Outcome Measure

Intraocular pressure [ Time Frame: up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford HealthDetroitMichigan48202
David A Crandall, MD
[email protected]
248-661-5100
Calvin Robbins, MD
[email protected]
313-916-3260
Nauman Imami, MD (SUB_INVESTIGATOR)
Paul Baciu, MD (SUB_INVESTIGATOR)
Brian Florek, MD (SUB_INVESTIGATOR)
Uma Jasty, MD (SUB_INVESTIGATOR)
Melisa Nika, MD (SUB_INVESTIGATOR)
Salma Noorulla, MD (SUB_INVESTIGATOR)
Candice Yousif, MD (SUB_INVESTIGATOR)

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By research site
Henry Ford Health· Detroit, MI

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