Pilocarpine
Drugpilocarpine hydrochloride ophthalmic solution 2% (20 mg/mL)
Other names: Isopto®
NCT Number: NCT03933631
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.
Interested in participating?
Request Info30 year–100 year
All sexes
Interventional
Phase 3
Montefiore Medical Center, The Bronx, New York, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
pilocarpine hydrochloride ophthalmic solution 2% (20 mg/mL)
Other names: Isopto®
Prednisolone acetate ophthalmic suspension 1%
Other names: Pred Forte
Ofloxacin Drops
Other names: Ocuflox, Floxin
Time frame: From baseline to 1 year following procedure
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.
Time frame: Up to 1 year following procedure
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.
Time frame: Up to 1 year following procedure
The number and type of ocular hypotensive medications used following the procedure will be summarized by study arm using descriptive statistics.
Time frame: Up to 1 year following procedure
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.
Time frame: Up to 1 year following procedure
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.
Time frame: Up to 1 year following procedure
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.
Contact information is provided by the study sponsor or research team.
Montefiore Medical Center
Other
A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Kahook Dual Blade Surgery
Acronym: PAACK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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