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Pilocarpine Use After Kahook Goniotomy

NCT ID: NCT03933631

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2028-12-31

Brief Summary

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

Detailed Description

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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. 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. 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.

Pilocarpine, a parasympathomimetic agent, is a glaucoma medication that works by causing contraction of the ciliary muscle leading to opening of the trabecular meshwork. 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 rationale 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.

Conditions

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Glaucoma

Keywords

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Cataract Glaucoma Surgery Vision Cataract Surgery Eye surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The "Treatment Group" will use 2% pilocarpine in the postoperative period in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin). The "Control Group" will use only Prednisolone acetate and Ofloxacin, without pilocarpine.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pilocarpine, Prednisolone acetate and Ofloxacin

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

Group Type EXPERIMENTAL

Pilocarpine

Intervention Type DRUG

pilocarpine hydrochloride ophthalmic solution 2% (20 mg/mL)

Prednisolone

Intervention Type DRUG

Prednisolone acetate ophthalmic suspension 1%

Ofloxacin

Intervention Type DRUG

Ofloxacin Drops

Prednisolone acetate and Ofloxacin (standard of care)

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

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

Prednisolone acetate ophthalmic suspension 1%

Ofloxacin

Intervention Type DRUG

Ofloxacin Drops

Interventions

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Pilocarpine

pilocarpine hydrochloride ophthalmic solution 2% (20 mg/mL)

Intervention Type DRUG

Prednisolone

Prednisolone acetate ophthalmic suspension 1%

Intervention Type DRUG

Ofloxacin

Ofloxacin Drops

Intervention Type DRUG

Other Intervention Names

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Isopto® Pred Forte Ocuflox Floxin

Eligibility Criteria

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Inclusion Criteria

* Patients with ocular hypertension or open angle glaucoma undergoing combined cataract surgery with KDB in a single surgical center at Montefiore Medical Center with a single provider

Exclusion Criteria

* Patients with previous history of eye surgeries (including laser procedures)
Minimum Eligible Age

30 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wen-Jeng (Melissa) Yao, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Montefiore Wakefield Campus

The Bronx, New York, United States

Site Status RECRUITING

Montefiore Medical Center

The Bronx, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Wen-Jeng (Melissa) Yao, MD

Role: CONTACT

Phone: 718-920-2020

Email: [email protected]

Facility Contacts

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Wen-Jeng (Melissa) Yao, MD

Role: primary

References

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Hu K, Gazzard G, Bunce C, Wormald R. Ab interno trabecular bypass surgery with Trabectome for open angle glaucoma. Cochrane Database Syst Rev. 2016 Aug 15;(8):CD011693. doi: 10.1002/14651858.CD011693.pub2.

Reference Type BACKGROUND
PMID: 27526051 (View on PubMed)

Johnson M. 'What controls aqueous humour outflow resistance?'. Exp Eye Res. 2006 Apr;82(4):545-57. doi: 10.1016/j.exer.2005.10.011. Epub 2006 Jan 4.

Reference Type BACKGROUND
PMID: 16386733 (View on PubMed)

Seibold LK, Soohoo JR, Ammar DA, Kahook MY. Preclinical investigation of ab interno trabeculectomy using a novel dual-blade device. Am J Ophthalmol. 2013 Mar;155(3):524-529.e2. doi: 10.1016/j.ajo.2012.09.023. Epub 2012 Dec 4.

Reference Type BACKGROUND
PMID: 23218696 (View on PubMed)

Swaminathan SS, Monsalve P, Zhou XY, Enriquez-Algeciras M, Bhattacharya SK, Dubovy SR, Junk AK. Histologic Analysis of Trabecular Meshwork Obtained From Kahook Dual Blade Goniotomy. Am J Ophthalmol. 2018 Aug;192:198-205. doi: 10.1016/j.ajo.2018.05.028. Epub 2018 Jun 5.

Reference Type BACKGROUND
PMID: 29883587 (View on PubMed)

Other Identifiers

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2018-9829

Identifier Type: -

Identifier Source: org_study_id