Pilocarpine Use After Kahook Goniotomy

Overview

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

Full Title of Study: “A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Kahook Dual Blade Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2025

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[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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Pilocarpine, Prednisolone acetate and Ofloxacin
    • This group will use 2% pilocarpine in the postoperative period in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)
  • Active Comparator: Prednisolone acetate and Ofloxacin (standard of care)
    • This group will use only Prednisolone acetate and Ofloxacin, without pilocarpine.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of patients with lowering of intraocular pressure (IOP)
    • Time Frame: Up to 1 year
    • The percentage of patients who had a reduction in IOP of 20% or more from baseline

Secondary Measures

  • Proportion of patients whose regimen was reduced by 1 medication or more
    • Time Frame: Up to 1 year
  • Rate of progression towards further glaucoma surgeries
    • Time Frame: Up to 1 year

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Montefiore Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wen-Jeng (Melissa) Yao, MD, Principal Investigator, Montefiore Medical Center
  • Overall Contact(s)
    • Wen-Jeng (Melissa) Yao, MD, 718-920-2020, WYAO@montefiore.org

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