Pilocarpine After Combined Cataract/Trabectome Surgery (PACCT)

A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Trabectome Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Drug: Pilocarpine; Drug: Ofloxacin; Drug: Prednisolone

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; 2% pilocarpine and standard of care post op drops ( Prednisolone acetate and Ofloxacin)	Drug: Pilocarpine; 2% pilocarpine in the postoperative period in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin); Other Names: Ocu-Carpine; Drug: Ofloxacin; Standard of care; Other Names: Ocuflox; Drug: Prednisolone; Standard of Care; Other Names: Ocu-Pred
Active Comparator: Control Group; Standard of care post op drops-Prednisolone acetate and Ofloxacin, without pilocarpine	Drug: Ofloxacin; Standard of care; Other Names: Ocuflox; Drug: Prednisolone; Standard of Care; Other Names: Ocu-Pred

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of intraocular lowering from baseline	Percentage of IOP drop at 1 month, 6 months and 1 year after surgery.	Up to 1 year
Number of IOP lowering agents required to achieve goal IOP	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	Up to 3 years
Rate of progression to further glaucoma surgeries.	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	Up to 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Wen-Jeng (Melissa) Yao, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2019
• Primary Completion (Actual): January 21, 2021
• Study Completion (Actual): January 21, 2021

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Cataract surgery; Vision; Trabectome; Eye Surgery; Glaucoma Surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Cataract; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cholinergic Agonists; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Miotics; Muscarinic Agonists; Prednisolone; Ofloxacin; Pilocarpine
• Other Study ID Numbers: 2017-8704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes