Pilocarpine Use After Kahook Goniotomy

NCT03933631 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 2018-9829
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Glaucoma

Keywords

Cataract; Glaucoma Surgery; Vision; Cataract Surgery; Eye surgery

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with lowering of intraocular pressure (IOP)

  The percentage of patients who had a reduction in IOP of 20% or more from baseline will be summarized by study arm using descriptive statistics.

  From baseline to 1 year following procedure

Secondary Outcomes (5)

• Proportion of patients whose regimen was reduced by 1 medication or more

  Up to 1 year following procedure

• Hypotensive medications

  Up to 1 year following procedure

• Rate of progression towards further glaucoma surgery - Humphrey Visual Fields (HVF)

  Up to 1 year following procedure

• Rate of progression towards further glaucoma surgery - Optical Coherence Tomography (OCT)

  Up to 1 year following procedure

• Need for additional glaucoma surgery

  Up to 1 year following procedure

Study Arms (2)

Pilocarpine, Prednisolone acetate and Ofloxacin

EXPERIMENTAL

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

Drug: Pilocarpine; Drug: Prednisolone; Drug: Ofloxacin

Prednisolone acetate and Ofloxacin (standard of care)

ACTIVE COMPARATOR

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

Drug: Prednisolone; Drug: Ofloxacin

Interventions

Pilocarpine DRUG

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

Also known as: Isopto®

Pilocarpine, Prednisolone acetate and Ofloxacin

Prednisolone DRUG

Prednisolone acetate ophthalmic suspension 1%

Also known as: Pred Forte

Pilocarpine, Prednisolone acetate and Ofloxacin; Prednisolone acetate and Ofloxacin (standard of care)

Ofloxacin DRUG

Ofloxacin Drops

Also known as: Ocuflox, Floxin

Pilocarpine, Prednisolone acetate and Ofloxacin; Prednisolone acetate and Ofloxacin (standard of care)

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (2)

Montefiore Wakefield Campus

The Bronx, New York, 10466, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 27526051 BACKGROUND

• 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.

  PMID: 16386733 BACKGROUND

• 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.

  PMID: 23218696 BACKGROUND

• 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.

  PMID: 29883587 BACKGROUND

MeSH Terms

Conditions

Glaucoma; Cataract

Interventions

Pilocarpine; Prednisolone; prednisolone acetate; Ofloxacin

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Wen-Jeng (Melissa) Yao, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Jeng (Melissa) Yao, MD

CONTACT

718-920-2020; WYAO@montefiore.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 1, 2019
• Study Start: May 1, 2019
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)