Pilocarpine Use After Kahook Goniotomy

Glaucoma Clinical Trial

— PAACK  

Official title:

A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Kahook Dual Blade Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03933631
• Other study ID #: 2018-9829
• Status: Recruiting
• Phase: Phase 3
• Start date: May 1, 2019
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: Montefiore Medical Center
• Contact: Wen-Jeng (Melissa) Yao, MD
• Phone: 718-920-2020
• Email: WYAO[@]montefiore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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[1]. 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[1]. 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[2].

Pilocarpine, a parasympathomimetic agent, is a glaucoma medication that works by causing contraction of the ciliary muscle leading to opening of the trabecular meshwork[3]. 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 rational 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients with ocular hypertension or open angle glaucoma undergoing combined cataract surgery with KDB

Exclusion Criteria:

• Patients with previous history of eye surgeries (including laser procedures)

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Pilocarpine
pilocarpine hydrochloride ophthalmic solution 2% (20 mg/mL)
• Prednisolone
Prednisolone acetate ophthalmic suspension 1%
• Ofloxacin
Ofloxacin Drops

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Montefiore Wakefield Campus	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with lowering of intraocular pressure (IOP)	The percentage of patients who had a reduction in IOP of 20% or more from baseline	Up to 1 year
Secondary	Proportion of patients whose regimen was reduced by 1 medication or more		Up to 1 year
Secondary	Rate of progression towards further glaucoma surgeries		Up to 1 year