Clinical trial NCT04005079: Pilocarpine After Combined Cataract/Trabectome Surgery
Official title: A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Trabectome Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Open Angle Glaucoma
Ocular Hypertension
Keywords: Cataract surgery
Trabectome
Eye Surgery
Vision
Glaucoma Surgery
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The "Treatment Group" will use 2% pilocarpine in the postoperative period in addition to standard post-operative drops (Prednisolone acetate and Ofloxacin). The "Control Group" will use only Prednisolone acetate and Ofloxacin, without pilocarpine.
Primary purpose: TREATMENT

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

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of intraocular lowering from baseline
timeFrame: Up to 1 year
measure: Number of IOP lowering agents required to achieve goal IOP
timeFrame: Up to 3 years
measure: Rate of progression to further glaucoma surgeries.
timeFrame: Up to 3 years
Secondary outcomes:
measure: Frequency of pilocarpine related side effects
timeFrame: Up to 3 years
measure: Frequency of drug discontinuation due to pilocarpine related side effects
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Wen-Jeng (Melissa) Yao, MD
role: PRINCIPAL_INVESTIGATOR
References: