Pilocarpine Use After Kahook Goniotomy (PAACK)

Montefiore Medicine Academic Health System

Status and phase: Suspended; Phase 3

Conditions: Glaucoma

Treatments: Drug: Ofloxacin; Drug: Pilocarpine; Drug: Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT03933631

2018-9829

Details and patient eligibility

About

The goal of this study is to determine whether using pilocarpine provides added benefit to the success of combined cataract + KDB surgery.

Full description

Glaucoma is the leading cause of irreversible blindness worldwide, and its treatment consists of lowering intraocular pressure to prevent damage to the optic nerve and loss of vision[1]. Current methods for lowering intraocular pressure (IOP) include topical and oral medications, laser trabeculoplasty, microincisional glaucoma surgery (MIGS), and traditional incisional surgeries such as trabeculectomy and aqueous tube shunts. 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[1]. There are multiple available MIGS procedures, most of which act by increasing trabecular outflow. One such procedure is the goniotomy via Kahook Dual Blade (KDB), which is usually performed in combination with cataract surgery. KDB is an FDA approved device used to perform a goniotomy via an internal approach. Strips of the nasal angle trabecular meshwork 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 goniotomy surgery. The rational for its use after goniotomy 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. This study will evaluate whether goniotomy via KDB / Cataract surgery without pilocarpine is non-inferior to the same surgery procedure followed by treatment with pilocarpine.

Enrollment: 142 estimated patients

Sex: All

Ages: 30 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with ocular hypertension or open angle glaucoma undergoing combined cataract surgery with KDB

Exclusion criteria

• Patients with previous history of eye surgeries (including laser procedures)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Pilocarpine, Prednisolone acetate and Ofloxacin

Experimental group

Description:

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

Treatment:

Drug: Prednisolone

Drug: Pilocarpine

Drug: Ofloxacin

Prednisolone acetate and Ofloxacin (standard of care)

Active Comparator group

Description:

This group will use only Prednisolone acetate and Ofloxacin, without pilocarpine.

Treatment:

Drug: Prednisolone

Drug: Ofloxacin