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Comparison of Goniotomy Device Outcomes in Combined Phacoemulsification-goniotomy Surgeries

Comparison of Goniotomy Device Outcomes in Combined Phacoemulsification-goniotomy Surgeries

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07418853
Enrollment
132
Registered
2026-02-18
Start date
2026-07-01
Completion date
2028-03-01
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

PROCEDUREGoniotomy

Goniotomy opens the trabecular meshwork to lower intraocular pressure.

Sponsors

Henry Ford Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults ≥ 18 years old * Diagnosed with primary or secondary open-angle glaucoma (e.g., POAG, pigmentary, pseudoexfoliative) * Scheduled for phacoemulsification with planned goniotomy * Able to provide informed consent

Exclusion criteria

* Angle-closure glaucoma * Prior glaucoma surgery in the study eye * Planned stand-alone goniotomy * Inability to comply with follow-up schedule

Design outcomes

Primary

MeasureTime frameDescription
Intraocular pressureup to 6 monthsEye pressure as measured by Goldmann applanation tonometry in mmHg
Medicationsup to 6 monthsnumber of medications to control intraocular pressure
Visual Acuityup to 6 monthsMeasure of visual at each visit on Snellen acuity chart

Countries

United States

Contacts

CONTACTDavid A Crandall, MD
dcranda1@hfhs.org248-661-5100
CONTACTCalvin Robbins, MD
crobbin5@hfhs.org313-916-3245
PRINCIPAL_INVESTIGATORDavid A Crandall, MD

Henry Ford Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026