Pilocarpine After Goniotomy for Glaucoma

(PAACK Trial)

Recruiting at 3 trial locations

Overseen By Wen-Jeng (Melissa) Yao, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Montefiore Medical Center

Disqualifiers: Previous eye surgeries

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 month

142 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding pilocarpine eye drops can improve outcomes for individuals undergoing combined cataract and glaucoma surgery using the Kahook Dual Blade (KDB). Participants will be divided into two groups: one will use pilocarpine along with standard post-surgery eye drops (Prednisolone acetate, a corticosteroid, and Ofloxacin, an antibiotic), while the other will use only the standard drops. The trial targets individuals with high eye pressure or open-angle glaucoma scheduled for this specific surgery, who have not undergone previous eye surgeries. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the validation of a potentially new treatment option.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that pilocarpine is usually well-tolerated, but it can cause some side effects. Studies have found that pilocarpine use can lead to headaches, blurred vision, and eye pain, with a 6.9% increase in headaches, a 3.1% increase in blurred vision, and a 2.4% increase in eye pain among users.

In contrast, both ofloxacin and prednisolone are commonly used in eye treatments and are generally considered safe. These medications often prevent infection and reduce swelling after eye surgery. Overall, previous research findings indicate that the treatment involving pilocarpine, prednisolone, and ofloxacin has manageable side effects and is considered safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for glaucoma?

Researchers are excited about pilocarpine for glaucoma treatment because it offers a new approach in the postoperative period following goniotomy, a surgical procedure. Unlike the standard care options that only use Prednisolone acetate and Ofloxacin to reduce inflammation and prevent infection, pilocarpine is added to potentially enhance the outcomes. Pilocarpine works by directly increasing the outflow of fluid from the eye, which may help in reducing intraocular pressure more effectively than traditional methods alone. This unique mechanism could lead to better control of glaucoma symptoms and improved recovery after surgery.

What evidence suggests that this trial's treatments could be effective for glaucoma?

This trial will compare pilocarpine eye drops with standard postoperative care following goniotomy surgery for glaucoma. Research has shown that pilocarpine might help glaucoma patients achieve better outcomes one month and one year post-surgery compared to those who do not use it. Pilocarpine may also reduce the need for additional glaucoma medications. Furthermore, its use has been linked to better short-term success after surgery. These findings suggest that pilocarpine could enhance the effectiveness of goniotomy surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Wen-Jeng (Melissa) Yao, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have high eye pressure or glaucoma and am getting cataract surgery with KDB.

Exclusion Criteria

I have had eye surgery or laser procedures in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo combined cataract and Kahook Dual Blade (KDB) surgery, followed by postoperative treatment with or without pilocarpine

1 month

1 visit (in-person) for surgery, followed by routine postoperative visits

Follow-up

Participants are monitored for safety and effectiveness, including IOP reduction and need for additional glaucoma surgery

Up to 1 year

Routine postoperative monitoring visits

What Are the Treatments Tested in This Trial?

Interventions

• Ofloxacin
• Pilocarpine
• Prednisolone

Trial Overview 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.

How Is the Trial Designed?

Group I: Pilocarpine, Prednisolone acetate and Ofloxacin Experimental Treatment 3 Interventions

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

Group II: Prednisolone acetate and Ofloxacin (standard of care) Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Citations

1. news.cuanschutz.edu news.cuanschutz.edu/ophthalmology/study-using-pilocarpine-drops-post-goniotomy-may-reduce-long-term-glaucoma-medication-needs

Study: Using Pilocarpine Drops Post Goniotomy May ... The group using pilocarpine drops had a significantly higher success rate in the first and third month after surgery as well as one year after ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12494916/

Two-Year Outcomes of Goniotomy After Failed Surgery for ... Conclusions. Goniotomy proves to be a safe and effective procedure for patients with previous failed glaucoma surgery over the 24-month study ...

3. tandfonline.com tandfonline.com/doi/abs/10.1080/02713683.2025.2464795

Postoperative Use of Pilocarpine After Kahook Dual Blade ... The use of pilocarpine postoperatively may improve surgical success and may reduce the number of glaucoma medications needed after goniotomy.

4. ophthalmology360.com ophthalmology360.com/conference-roundup/pilocarpine-response-may-predict-short-term-success-of-kahook-dual-blade-goniotomy-study-finds/

Pilocarpine response may predict short-term success of ... KDB was successful in 62.5% of patients at postoperative Week 1, 55.0% at 1 month, and 47.4% at 3 months. By the 3-month mark, the average IOP decreased by 3.3 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03933631

NCT03933631 | Pilocarpine Use After Kahook Goniotomy While the theoretical benefit of pilocarpine has been proposed, its actual benefit has never been proven. This study will evaluate whether goniotomy via KDB / ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40359054/

Effect of Postoperative Pilocarpine Eyedrops in the ... Routine postoperative pilocarpine use following GATT did not appear to significantly impact surgical outcomes or complication rates.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0149291823004782

Efficacy and Safety of CSF-1 (0.4% Pilocarpine ... Results showed that 0.4% pilocarpine HCl was the minimum concentration needed to achieve near vision improvement without compromising distance visual acuity, ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40835063/

Short-Term Efficacy and Safety of Pilocarpine Ophthalmic ... Conclusion: Pilocarpine demonstrated short-term efficacy in improving near vision in presbyopic patients, with an increased incidence of ...

9. fda.gov fda.gov/media/79043/download

Statistical Review and Evaluation have very little IOP assessments and mostly safety data on pilocarpine arm. ... pilocarpine alone and timolol alone in the treatment of glaucoma.

10. ajo.com ajo.com/article/S0002-9394(25)00439-8/abstract

Short-Term Efficacy and Safety of Pilocarpine Ophthalmic ... Pilocarpine increased the risk of headache (+6.9%; OR 3.02, 95% CI 1.53-5.93), blurred vision (+3.1%; OR 4.93, 95% CI 1.92-12.65), and eye pain (+2.4%; OR 4.26, ...