Pilocarpine After Goniotomy for Glaucoma
(PAACK Trial)
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.12345Why 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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo combined cataract and Kahook Dual Blade (KDB) surgery, followed by postoperative treatment with or without pilocarpine
Follow-up
Participants are monitored for safety and effectiveness, including IOP reduction and need for additional glaucoma surgery
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?
2
Treatment groups
Experimental Treatment
Active Control
This group will use 2% pilocarpine in the postoperative period, for one month, in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)
This group will use only the standard Prednisolone acetate and Ofloxacin, without pilocarpine.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montefiore Medical Center
Lead Sponsor
Citations
1.
news.cuanschutz.edu
news.cuanschutz.edu/ophthalmology/study-using-pilocarpine-drops-post-goniotomy-may-reduce-long-term-glaucoma-medication-needsStudy: 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 ...
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 ...
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 ...
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 / ...
Effect of Postoperative Pilocarpine Eyedrops in the ...
Routine postoperative pilocarpine use following GATT did not appear to significantly impact surgical outcomes or complication rates.
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, ...
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 ...
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.
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, ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.