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AzTrials

GlaucomaPhase 3PAACKNCT03933631

Pilocarpine Use After Kahook Goniotomy

A Phase 3 study testing Pilocarpine, Prednisolone and Ofloxacin in people with Glaucoma, run by Montefiore Medical Center at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 100 years
Conditions the study is for
Glaucoma
What is being tested?
Pilocarpine, Prednisolone and Ofloxacin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
2 sitesUnited States
Study dates
1 May 2019to Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wen-Jeng (Melissa) Yao, MD contact

718-920-2020

WYAO@montefiore.org

United States2 sites, 2 recruiting

  • Montefiore Wakefield Campus

    The Bronx, New York, 10466

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Wen-Jeng (Melissa) Yao, MD

    Wen-Jeng (Melissa) Yao, MD

    Recruiting

Other trials in United States

About this study

Official title: A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Kahook Dual Blade Surgery

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.

Read the detailed 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. 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
Glaucoma
Being tested
Pilocarpine, Prednisolone, Ofloxacin
Keywords
Cataract, Glaucoma Surgery, Vision, Cataract Surgery, Eye surgery
Medical subject headings
Glaucoma, Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PilocarpineDrug

    Also called Isopto®

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

  • PrednisoloneDrug

    Also called Pred Forte

    Prednisolone acetate ophthalmic suspension 1%

  • OfloxacinDrug

    Also called Ocuflox, Floxin

    Ofloxacin Drops

Study groups in NCT03933631
Study groupRoleWhat they receive
Pilocarpine, Prednisolone acetate and OfloxacinExperimentalThis group will use 2% pilocarpine in the postoperative period, for one month, in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)
Receives: Drug: Pilocarpine; Drug: Prednisolone; Drug: Ofloxacin
Prednisolone acetate and Ofloxacin (standard of care)Active comparatorThis group will use only the standard Prednisolone acetate and Ofloxacin, without pilocarpine.
Receives: Drug: Prednisolone; Drug: Ofloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From baseline to 1 year following procedure

Secondary outcomes (5)

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

    The proportion/percentage of patients whose regimen was reduced by 1 medication or more during each routine post-operative monitoring visit following the combined cataract and KDB surgery procedure will be summarized by study arm using descriptive statistics.

    Measured: Up to 1 year following procedure

  2. Hypotensive medications

    The number and type of ocular hypotensive medications used following the procedure will be summarized by study arm using descriptive statistics.

    Measured: Up to 1 year following procedure

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

    The rate of progression towards additional glaucoma surgeries will be assessed using Humphrey Visual Fields (HVF) testing. Automated HVF testing will be used to detect and monitor the progression of glaucoma by mapping the patient's peripheral vision and detecting areas of vision loss. The rate of progression is assessed through software that assesses both trend and event analysis. Software trend analysis will be used to quantify how much vision is lost up to 1 year. Visual field loss rate will be summarized by study arm and reported using descriptive statistics.

    Measured: Up to 1 year following procedure

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

    The rate of progression towards additional glaucoma surgery will also be assessed using OCT scanning. OCT scanning will be used to obtain a quantitative measurement of structural of the retinal nerve fiber layer over time. OCT can reveal structural changes that often precede functional visual field loss and be an earlier indicator of progression. The rate of structural loss over time as measured by change in retinal nerve fiber thickness will be summarized and reported by study arm and reported using descriptive statistics.

    Measured: Up to 1 year following procedure

  5. Need for additional glaucoma surgery

    The need for additional glaucoma surgery will be determined by the number of patients who require additional glaucoma surgery following the scheduled cataract and KDB surgery. The number/percentage of patients requiring additional glaucoma surgery will be summarized by study arm using descriptive statistics.

    Measured: Up to 1 year following procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2019
  2. Study start1 May 2019
  3. Primary completionJun 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03933631
Sponsor's protocol ID
2018-9829
Acronym
PAACK
Status last verified
Nov 2025
First submitted
26 Apr 2019
Last updated
10 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27526051

  • 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.

    PubMed 16386733

  • 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.

    PubMed 23218696

  • 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.

    PubMed 29883587

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pilocarpine, Prednisolone and Ofloxacin in people with Glaucoma, run by Montefiore Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wen-Jeng (Melissa) Yao, MD (718-920-2020, WYAO@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with lowering of intraocular pressure (IOP) (time frame: From baseline to 1 year following procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03933631, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.

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