Pilocarpine After Combined Cataract/Trabectome Surgery

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Pilocarpine
* Drug: Ofloxacin
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract surgery, Trabectome, Eye Surgery, Vision, Glaucoma Surgery