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Pilocarpine After Combined Cataract/Trabectome Surgery

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

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04005079
Acronym
PACCT
Enrollment
0
Registered
2019-07-02
Start date
2019-06-05
Completion date
2021-01-21
Last updated
2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Angle Glaucoma, Ocular Hypertension

Keywords

Cataract surgery, Trabectome, Eye Surgery, Vision, Glaucoma Surgery

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

Interventions

DRUGPilocarpine

2% pilocarpine in the postoperative period in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)

Standard of care

DRUGPrednisolone

Standard of Care

Sponsors

Montefiore Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
30 Years to 100 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Percentage of intraocular lowering from baselineUp to 1 yearPercentage of IOP drop at 1 month, 6 months and 1 year after surgery.
Number of IOP lowering agents required to achieve goal IOPUp to 3 yearsThe 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 yearsAssessment 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

MeasureTime frameDescription
Frequency of pilocarpine related side effectsUp to 3 yearsMost 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 effectsUp to 3 yearsThe number of drug discontinuation due to common side effects will be counted

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026