Pilocarpine After Combined Cataract/Trabectome Surgery (PACCT)
Primary Purpose
Open Angle Glaucoma, Ocular Hypertension
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Pilocarpine
Ofloxacin
Prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Cataract surgery, Trabectome, Eye Surgery, Vision, Glaucoma Surgery
Eligibility Criteria
Inclusion Criteria:
- Age Range: 30 to 100 years old
- Patients with ocular hypertension or open angle glaucoma undergoing combined cataract surgery with trabectome in a single surgical center
Exclusion Criteria:
- Patients with previous history of eye surgeries (including laser procedures).
Sites / Locations
- Montefiore Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment Group
Control Group
Arm Description
2% pilocarpine and standard of care post op drops ( Prednisolone acetate and Ofloxacin)
Standard of care post op drops-Prednisolone acetate and Ofloxacin, without pilocarpine
Outcomes
Primary Outcome Measures
Percentage of intraocular lowering from baseline
Percentage of IOP drop at 1 month, 6 months and 1 year after surgery.
Number of IOP lowering agents required to achieve goal IOP
The number of pre and post procedure drops required to achieve goal IOP at 6 months, 1, 2 and 3 years after combined cataract/trabectome surgery in patients treated with post-op pilocarpine vs control
Rate of progression to further glaucoma surgeries.
Assessment of the rate of progression towards further surgery in patients treated with post-op pilocarpine vs control over a 3 year follow up period
Secondary Outcome Measures
Frequency of pilocarpine related side effects
Most common side effects will be counted - blurry vision, decrease night vision, headaches, browache, nausea, vomiting, diarrhea
Frequency of drug discontinuation due to pilocarpine related side effects
The number of drug discontinuation due to common side effects will be counted
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04005079
Brief Title
Pilocarpine After Combined Cataract/Trabectome Surgery
Acronym
PACCT
Official Title
A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Trabectome Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
not performing Trabectomes
Study Start Date
June 5, 2019 (Actual)
Primary Completion Date
January 21, 2021 (Actual)
Study Completion Date
January 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
Combined cataract + trabectome surgery is a surgery designed to help lower the intraocular pressure (pressure in the eye) and hopefully reduce the need for topical drops, progression of glaucoma, and/or further glaucoma surgeries. The purpose of this study is to assess whether using pilocarpine, a medication which is FDA approved to induce miosis, (in other words cause the pupil to constrict or become smaller) provides additional benefit to the success of Trabectome and cataract surgery.
Detailed Description
Glaucoma is the leading cause of irreversible blindness worldwide, and its treatment consists of lowering intraocular pressure (IOP) to prevent damage to the optic nerve and loss of vision. Microincisional glaucoma surgery (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 Trabectome, which is usually performed in combination with cataract surgery.
Trabectome is an FDA approved device used to perform a trabeculectomy via an internal approach. A strip of 60-120 degrees of the nasal angle trabecular meshwork and the inner wall of Schlemm's canal are removed providing a direct pathway for aqueous outflow from the anterior chamber into the collector channels[2].
Pilocarpine, a parasympathomimetic agent, is a glaucoma medication that works by causing contraction of the ciliary muscle leading to opening of the trabecular meshwork[3]. 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 trabectome surgery.
The rationale for its use after Trabectome 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.
In this study, the aim is to evaluate whether Trabecome / Cataract surgery without pilocarpine is non-inferior to Trabecome / Cataract surgery procedure followed by treatment with pilocarpine
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension
Keywords
Cataract surgery, Trabectome, Eye Surgery, Vision, Glaucoma Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The "Treatment Group" will use 2% pilocarpine in the postoperative period in addition to standard post-operative drops (Prednisolone acetate and Ofloxacin). The "Control Group" will use only Prednisolone acetate and Ofloxacin, without pilocarpine.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
2% pilocarpine and standard of care post op drops ( Prednisolone acetate and Ofloxacin)
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Standard of care post op drops-Prednisolone acetate and Ofloxacin, without pilocarpine
Intervention Type
Drug
Intervention Name(s)
Pilocarpine
Other Intervention Name(s)
Ocu-Carpine
Intervention Description
2% pilocarpine in the postoperative period in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)
Intervention Type
Drug
Intervention Name(s)
Ofloxacin
Other Intervention Name(s)
Ocuflox
Intervention Description
Standard of care
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Other Intervention Name(s)
Ocu-Pred
Intervention Description
Standard of Care
Primary Outcome Measure Information:
Title
Percentage of intraocular lowering from baseline
Description
Percentage of IOP drop at 1 month, 6 months and 1 year after surgery.
Time Frame
Up to 1 year
Title
Number of IOP lowering agents required to achieve goal IOP
Description
The number of pre and post procedure drops required to achieve goal IOP at 6 months, 1, 2 and 3 years after combined cataract/trabectome surgery in patients treated with post-op pilocarpine vs control
Time Frame
Up to 3 years
Title
Rate of progression to further glaucoma surgeries.
Description
Assessment of the rate of progression towards further surgery in patients treated with post-op pilocarpine vs control over a 3 year follow up period
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Frequency of pilocarpine related side effects
Description
Most common side effects will be counted - blurry vision, decrease night vision, headaches, browache, nausea, vomiting, diarrhea
Time Frame
Up to 3 years
Title
Frequency of drug discontinuation due to pilocarpine related side effects
Description
The number of drug discontinuation due to common side effects will be counted
Time Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age Range: 30 to 100 years old
Patients with ocular hypertension or open angle glaucoma undergoing combined cataract surgery with trabectome in a single surgical center
Exclusion Criteria:
Patients with previous history of eye surgeries (including laser procedures).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Jeng (Melissa) Yao, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilocarpine After Combined Cataract/Trabectome Surgery
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