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Antibiotic

Pilocarpine After Goniotomy for Glaucoma (PAACK Trial)

Phase 3
Recruiting
Led By Wen-Jeng (Melissa) Yao, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with ocular hypertension or open angle glaucoma undergoing combined cataract surgery with KDB
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

PAACK Trial Summary

This trial will test whether adding pilocarpine to combined cataract + KDB surgery improves the chances of success.

Who is the study for?
This trial is for patients with high eye pressure or open angle glaucoma who are having cataract surgery along with a procedure called Kahook Dual Blade (KDB). People who've had previous eye surgeries, including laser treatments, can't participate.Check my eligibility
What is being tested?
The study is testing if pilocarpine drops help improve the success of combined cataract and KDB surgery. Patients will also use prednisolone and ofloxacin as part of their post-surgery care.See study design
What are the potential side effects?
Pilocarpine may cause headaches, brow aches, visual blurring, or eye irritation. Prednisolone could increase infection risk and raise eye pressure. Ofloxacin might lead to mild stinging or redness in the eyes.

PAACK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have high eye pressure or glaucoma and am getting cataract surgery with KDB.

PAACK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of patients with lowering of intraocular pressure (IOP)
Secondary outcome measures
Proportion of patients whose regimen was reduced by 1 medication or more
Rate of progression towards further glaucoma surgeries

Side effects data

From 2014 Phase 2 & 3 trial • 196 Patients • NCT00656513
11%
Dry mouth
2%
Gastrointestinal disorder
2%
Dysphagia
2%
Fatigue
2%
Taste alteration
100%
80%
60%
40%
20%
0%
Study treatment Arm
ALTENS: Phase II
ALTENS: Phase III
Pilocarpine: Phase III

PAACK Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pilocarpine, Prednisolone acetate and OfloxacinExperimental Treatment3 Interventions
This group will use 2% pilocarpine in the postoperative period in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)
Group II: Prednisolone acetate and Ofloxacin (standard of care)Active Control2 Interventions
This group will use only Prednisolone acetate and Ofloxacin, without pilocarpine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pilocarpine
FDA approved
Prednisolone
FDA approved
Ofloxacin
FDA approved

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,134 Total Patients Enrolled
1 Trials studying Glaucoma
Wen-Jeng (Melissa) Yao, MDPrincipal InvestigatorMontefiore Medical Center
1 Previous Clinical Trials
1 Trials studying Glaucoma

Media Library

Ofloxacin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03933631 — Phase 3
Glaucoma Research Study Groups: Pilocarpine, Prednisolone acetate and Ofloxacin, Prednisolone acetate and Ofloxacin (standard of care)
Glaucoma Clinical Trial 2023: Ofloxacin Highlights & Side Effects. Trial Name: NCT03933631 — Phase 3
Ofloxacin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03933631 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a risk of developing dependency to Pilocarpine?

"Pilocarpine has been given a safety rating of 3 by our team at Power. This is because Phase 3 trials have shown both efficacy and safety in multiple rounds of testing."

Answered by AI

Are there other existing research papers on Pilocarpine?

"Out of the 95 ongoing studies on pilocarpine, 35 are in the final stage before FDA approval. The majority of these are based in Geneva and New South Wales, but there are 3008 total locations running clinical trials for this medication."

Answered by AI

Are we enrolling new participants in this research at this time?

"This particular trial, as indicated by clinicaltrials.gov, is not currently looking for patients. Although, this may be subject to change as the trial was last updated on September 16th, 2022. Out of the 302 other trials, this is the only one that is not searching for participants."

Answered by AI

What is the maximum sample size for this experiment?

"This particular trial is no longer recruiting patients. However, as of September 16th, 2022, there are 207 trials for patients with glaucoma and 95 studies for Pilocarpine actively enrolling participants."

Answered by AI

What medical condition is Pilocarpine used to treat?

"Pilocarpine is a medication that is typically used to treat ulcerative colitis. It can also be effective in treating other conditions such as varicella-zoster virus acute retinal necrosis, brain, and inflamed external hemorrhoids."

Answered by AI

Am I eligible to join this experiment?

"The study is currently looking for 142 individuals aged 30 to 100 that have been diagnosed with glaucoma. To be eligible, patients must also have ocular hypertension or open angle glaucoma and be scheduled for cataract surgery with KDB."

Answered by AI

Would this experiment be beneficial for elderly individuals?

"This study requires that participants are aged 30 or older, and no older than 100."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pilocarpine Use After Kahook Goniotomy
Melissa Wen-Jeng Yao 2019. "Pilocarpine Use After Kahook Goniotomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03933631.
All > Glaucoma New York > Glaucoma
~34 spots leftby Dec 2025
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