Brief 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.
Brief Title
Pilocarpine Use After Kahook Goniotomy
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Glaucoma
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Patients with previous history of eye surgeries (including laser procedures)
* 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
Exclusion Criteria:
* Patients with previous history of eye surgeries (including laser procedures)
Inclusion Criteria
Inclusion Criteria:
* 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
* 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
Gender
All
Gender Based
false
Keywords
Cataract
Glaucoma Surgery
Vision
Cataract Surgery
Eye surgery
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
100 Years
Minimum Age
30 Years
NCT Id
NCT03933631
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2018-9829
Overall Status
Suspended
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Kahook Dual Blade Surgery
Primary Outcomes
Outcome Description
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.
Outcome Measure
Percentage of patients with lowering of intraocular pressure (IOP)
Outcome Time Frame
From baseline to 1 year following procedure
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Up to 1 year following procedure
Outcome Measure
Proportion of patients whose regimen was reduced by 1 medication or more
Outcome Description
The number and type of ocular hypotensive medications used following the procedure will be summarized by study arm using descriptive statistics.
Outcome Time Frame
Up to 1 year following procedure
Outcome Measure
Hypotensive medications
Outcome Description
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.
Outcome Time Frame
Up to 1 year following procedure
Outcome Measure
Rate of progression towards further glaucoma surgery - Humphrey Visual Fields (HVF)
Outcome Description
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.
Outcome Time Frame
Up to 1 year following procedure
Outcome Measure
Rate of progression towards further glaucoma surgery - Optical Coherence Tomography (OCT)
Outcome Description
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.
Outcome Time Frame
Up to 1 year following procedure
Outcome Measure
Need for additional glaucoma surgery
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
100
Minimum Age Number (converted to Years and rounded down)
30
Investigators
Investigator Type
Principal Investigator
Investigator Name
Wen- Jeng Melissa Yao
Investigator Email
wyao@montefiore.org
Categories Mesh Debug
Vision/Eye --- GLAUCOMA
Vision/Eye --- OCULAR HYPERTENSION
Vision/Eye --- EYE DISEASES
MeSH Terms
GLAUCOMA
CATARACT
OCULAR HYPERTENSION
EYE DISEASES
LENS DISEASES
PILOCARPINE
PREDNISOLONE
PREDNISOLONE ACETATE
OFLOXACIN
ALKALOIDS
HETEROCYCLIC COMPOUNDS
PREGNADIENETRIOLS
PREGNADIENES
PREGNANES
STEROIDS
FUSED-RING COMPOUNDS
POLYCYCLIC COMPOUNDS
FLUOROQUINOLONES
4-QUINOLONES
QUINOLONES
QUINOLINES
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING