Pilocarpine Use After Kahook Goniotomy

Phase 3

Suspended

• Conditions: Glaucoma
• Interventions: Drug: Pilocarpine; Drug: Prednisolone; Drug: Ofloxacin

• Registration Number: NCT03933631
• Lead Sponsor: Montefiore Medical Center

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.

Detailed Description

Glaucoma is the leading cause of irreversible blindness worldwide, and its treatment consists of lowering intraocular pressure to prevent damage to the optic nerve and loss of vision. Current methods for lowering intraocular pressure (IOP) include topical and oral medications, laser trabeculoplasty, microincisional glaucoma surgery (MIGS), and traditional incisional surgeries such as trabeculectomy and aqueous tube shunts. MIGS have become more popular in recent years as less invasive methods than traditional surgeries that effectively reduce IOP and help reduce the medication burden on patients. There are multiple available MIGS procedures, most of which act by increasing trabecular outflow. One such procedure is the goniotomy via Kahook Dual Blade (KDB), which is usually performed in combination with cataract surgery. KDB is an FDA approved device used to perform a goniotomy via an internal approach. Strips of the nasal angle trabecular meshwork are removed providing a direct pathway for aqueous outflow from the anterior chamber into the collector channels.

Pilocarpine, a parasympathomimetic agent, is a glaucoma medication that works by causing contraction of the ciliary muscle leading to opening of the trabecular meshwork. Due to its frequent dosing requirement and large number of ocular and systemic side effects, pilocarpine has largely fallen out of favor for the treatment of primary open angle glaucoma (POAG), except in patients for whom few other alternatives exist. However, pilocarpine is often used after goniotomy surgery. The rationale for its use after goniotomy procedure is for its miotic effect, which theoretically may prevent the formation of peripheral anterior synechiae. Formation of peripheral anterior synechiae can lead to the closure of the cleft that is generated and the possibility of failure of the procedure. While the theoretical benefit of pilocarpine has been proposed, its actual benefit has never been proven. This study will evaluate whether goniotomy via KDB / Cataract surgery without pilocarpine is non-inferior to the same surgery procedure followed by treatment with pilocarpine.

Study Timeline

• Study First Submitted: 2019-04-26
• Study First Submitted QC: 2019-04-29
• Study Start: 2019-05-01
• Study First Posted: 2019-05-01
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-16
• Last Update Posted: 2025-09-22
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 142

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pilocarpine, Prednisolone acetate and Ofloxacin	Pilocarpine	This group will use 2% pilocarpine in the postoperative period, for one month, in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)
Pilocarpine, Prednisolone acetate and Ofloxacin	Prednisolone	This group will use 2% pilocarpine in the postoperative period, for one month, in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)
Pilocarpine, Prednisolone acetate and Ofloxacin	Ofloxacin	This group will use 2% pilocarpine in the postoperative period, for one month, in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)
Prednisolone acetate and Ofloxacin (standard of care)	Prednisolone	This group will use only the standard Prednisolone acetate and Ofloxacin, without pilocarpine.
Prednisolone acetate and Ofloxacin (standard of care)	Ofloxacin	This group will use only the standard Prednisolone acetate and Ofloxacin, without pilocarpine.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with lowering of intraocular pressure (IOP)	From baseline to 1 year following procedure	The percentage of patients who had a reduction in IOP of 20% or more from baseline will be summarized by study arm using descriptive statistics.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients whose regimen was reduced by 1 medication or more	Up to 1 year following procedure	The proportion/percentage of patients whose regimen was reduced by 1 medication or more during each routine post-operative monitoring visit following the combined cataract and KDB surgery procedure will be summarized by study arm using descriptive statistics.
Hypotensive medications	Up to 1 year following procedure	The number and type of ocular hypotensive medications used following the procedure will be summarized by study arm using descriptive statistics.
Rate of progression towards further glaucoma surgery - Humphrey Visual Fields (HVF)	Up to 1 year following procedure	The rate of progression towards additional glaucoma surgeries will be assessed using Humphrey Visual Fields (HVF) testing. Automated HVF testing will be used to detect and monitor the progression of glaucoma by mapping the patient's peripheral vision and detecting areas of vision loss. The rate of progression is assessed through software that assesses both trend and event analysis. Software trend analysis will be used to quantify how much vision is lost up to 1 year. Visual field loss rate will be summarized by study arm and reported using descriptive statistics.
Rate of progression towards further glaucoma surgery - Optical Coherence Tomography (OCT)	Up to 1 year following procedure	The rate of progression towards additional glaucoma surgery will also be assessed using OCT scanning. OCT scanning will be used to obtain a quantitative measurement of structural of the retinal nerve fiber layer over time. OCT can reveal structural changes that often precede functional visual field loss and be an earlier indicator of progression. The rate of structural loss over time as measured by change in retinal nerve fiber thickness will be summarized and reported by study arm and reported using descriptive statistics.
Need for additional glaucoma surgery	Up to 1 year following procedure	The need for additional glaucoma surgery will be determined by the number of patients who require additional glaucoma surgery following the scheduled cataract and KDB surgery. The number/percentage of patients requiring additional glaucoma surgery will be summarized by study arm using descriptive statistics.

Trial Locations

Locations (2)

Montefiore Wakefield Campus; 🇺🇸 The Bronx, New York, United States

Montefiore Medical Center; 🇺🇸 The Bronx, New York, United States