Pilocarpine after cataract and Kahook goniotomy
A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Kahook Dual Blade Surgery
This trial will test whether giving pilocarpine after combined cataract and Kahook Dual Blade surgery helps lower eye pressure and reduce the need for glaucoma medicines in people with open-angle glaucoma or ocular hypertension.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 30 Years to 100 Years |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 2 sites (The Bronx, New York and 1 other locations) |
| Trial ID | NCT03933631 on ClinicalTrials.gov |
What this trial studies
This single-center Phase 3 interventional study enrolls patients having combined cataract surgery with Kahook Dual Blade goniotomy to see if adding postoperative pilocarpine improves surgical success. Participants receive standard postoperative care including topical steroid and antibiotic with pilocarpine added for the intervention group, and outcomes such as intraocular pressure and medication burden are tracked over follow-up. The Kahook procedure removes strips of trabecular meshwork to improve aqueous outflow, while pilocarpine acts by tightening the ciliary muscle and opening trabecular spaces. The trial is conducted at Montefiore with a single provider to standardize surgical technique and postoperative management.
Who should consider this trial
Good fit: Adults with ocular hypertension or open-angle glaucoma who are scheduled for combined cataract surgery with Kahook Dual Blade goniotomy at Montefiore and have no prior eye surgeries are ideal candidates.
Not a fit: Patients with prior intraocular surgeries, other types of glaucoma not appropriate for KDB, or those who cannot tolerate pilocarpine side effects are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, adding pilocarpine could further lower intraocular pressure after cataract+KDB surgery and reduce reliance on glaucoma medications.
How similar studies have performed: Pilocarpine is a well-known glaucoma drug but its routine postoperative use after KDB goniotomy is not well studied, and previous work on adjunctive medical therapies for MIGS has shown mixed results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with ocular hypertension or open angle glaucoma undergoing combined cataract surgery with KDB in a single surgical center at Montefiore Medical Center with a single provider Exclusion Criteria: * Patients with previous history of eye surgeries (including laser procedures)
Where this trial is running
The Bronx, New York and 1 other locations
- Montefiore Wakefield Campus — The Bronx, New York, United States (Recruiting)
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Wen-Jeng (Melissa) Yao, MD — Montefiore Medical Center
- Study coordinator: Wen-Jeng (Melissa) Yao, MD
- Email: WYAO@montefiore.org
- Phone: 718-920-2020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.