Recruiting
Phase 3

Pilocarpine

Sponsor:

Montefiore Medical Center

Code:

NCT03933631

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Pilocarpine

Prednisolone

Ofloxacin

Study Details

Brief summary:

The goal of this study is to determine whether using pilocarpine provides added benefit to the success of combined cataract + Kahook Dual Blade (KDB) surgery.

Conditions

Glaucoma

Study ID

NCT03933631

Start date

May 1, 2019

Status verified date

Nov, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

142 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pilocarpine, Prednisolone acetate and Ofloxacin

This group will use 2% pilocarpine in the postoperative period, for one month, in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)

active comparator: Prednisolone acetate and Ofloxacin (standard of care)

This group will use only the standard Prednisolone acetate and Ofloxacin, without pilocarpine.

Interventions

Pilocarpine

pilocarpine hydrochloride ophthalmic solution 2% (20 mg/mL)

Prednisolone

Prednisolone acetate ophthalmic suspension 1%

Ofloxacin

Ofloxacin Drops

Primary outcome measure

  • Percentage of patients with lowering of intraocular pressure (IOP) [ Time Frame: From baseline to 1 year following procedure ]

Central Contacts and Locations

Central contacts

Wen-Jeng (Melissa) Yao, MD

718-920-2020WYAO@montefiore.org

Locations

Montefiore Wakefield Campus

Recruiting

The Bronx, New York, United States, 10466

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Principal Investigator:

Wen-Jeng (Melissa) Yao, MD

More Information

Sponsor

Montefiore Medical Center

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • Cataract
  • Glaucoma Surgery
  • Vision
  • Cataract Surgery
  • Eye surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2025-11-10.