Pilocarpine After Combined Cataract/Trabectome Surgery

Phase 3

Withdrawn

• Conditions: Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Pilocarpine; Drug: Ofloxacin; Drug: Prednisolone

• Registration Number: NCT04005079
• Lead Sponsor: Montefiore Medical Center

Brief Summary

Combined cataract + trabectome surgery is a surgery designed to help lower the intraocular pressure (pressure in the eye) and hopefully reduce the need for topical drops, progression of glaucoma, and/or further glaucoma surgeries. The purpose of this study is to assess whether using pilocarpine, a medication which is FDA approved to induce miosis, (in other words cause the pupil to constrict or become smaller) provides additional benefit to the success of Trabectome and cataract surgery.

Detailed Description

Glaucoma is the leading cause of irreversible blindness worldwide, and its treatment consists of lowering intraocular pressure (IOP) to prevent damage to the optic nerve and loss of vision. Microincisional glaucoma surgery (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 Trabectome, which is usually performed in combination with cataract surgery.

Trabectome is an FDA approved device used to perform a trabeculectomy via an internal approach. A strip of 60-120 degrees of the nasal angle trabecular meshwork and the inner wall of Schlemm's canal 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 trabectome surgery.

The rationale for its use after Trabectome 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.

In this study, the aim is to evaluate whether Trabecome / Cataract surgery without pilocarpine is non-inferior to Trabecome / Cataract surgery procedure followed by treatment with pilocarpine

Study Timeline

• Study Start: 2019-06-05
• Study First Submitted: 2019-06-28
• Study First Submitted QC: 2019-06-28
• Study First Posted: 2019-07-02
• Primary Completion: 2021-01-21
• Study Completion: 2021-01-21
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age Range: 30 to 100 years old
• Patients with ocular hypertension or open angle glaucoma undergoing combined cataract surgery with trabectome in a single surgical center

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
Treatment Group	Ofloxacin	2% pilocarpine and standard of care post op drops ( Prednisolone acetate and Ofloxacin)
Treatment Group	Prednisolone	2% pilocarpine and standard of care post op drops ( Prednisolone acetate and Ofloxacin)
Control Group	Ofloxacin	Standard of care post op drops-Prednisolone acetate and Ofloxacin, without pilocarpine
Treatment Group	Pilocarpine	2% pilocarpine and standard of care post op drops ( Prednisolone acetate and Ofloxacin)
Control Group	Prednisolone	Standard of care post op drops-Prednisolone acetate and Ofloxacin, without pilocarpine

Primary Outcome Measures

Name	Time	Method
Percentage of intraocular lowering from baseline	Up to 1 year	Percentage of IOP drop at 1 month, 6 months and 1 year after surgery.
Number of IOP lowering agents required to achieve goal IOP	Up to 3 years	The number of pre and post procedure drops required to achieve goal IOP at 6 months, 1, 2 and 3 years after combined cataract/trabectome surgery in patients treated with post-op pilocarpine vs control
Rate of progression to further glaucoma surgeries.	Up to 3 years	Assessment of the rate of progression towards further surgery in patients treated with post-op pilocarpine vs control over a 3 year follow up period

Secondary Outcome Measures

Name	Time	Method
Frequency of pilocarpine related side effects	Up to 3 years	Most common side effects will be counted - blurry vision, decrease night vision, headaches, browache, nausea, vomiting, diarrhea
Frequency of drug discontinuation due to pilocarpine related side effects	Up to 3 years	The number of drug discontinuation due to common side effects will be counted

Trial Locations

Locations (1)

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