Study of the CycloPen Micro-Interventional System and Long-Term Clinical Outcomes
- Conditions
- Open Angle Glaucoma
- Interventions
- Device: CycloPen Cyclodialysis System
- Registration Number
- NCT05506423
- Lead Sponsor
- Iantrek, Inc.
- Brief Summary
This observational study will enroll adults with open angle glaucoma (OAG) who had surgery to reduce intraocular pressure (IOP) using the CycloPen Micro-Interventional System. Consenting participants will be followed for 24 months after their surgery.
Data regarding IOP, use of glaucoma medications, and any side effects related to the surgery will be collected from participants' preoperative examination, their surgery, and postoperative examinations.
- Detailed Description
This is a multicenter, observational registry of eligible adults with open angle glaucoma (OAG) in whom IOP-lowering surgery with the CycloPen Micro-Interventional System was performed are consecutively enrolled.
Data will be collected from the preoperative visit(s) that directly preceded surgery, the surgical procedure, and postoperative visits through 24 months after CycloPen System use.
Specific data to be collected includes details of the CycloPen surgical procedure, IOP, use of ocular hypotensive medications, and any side effects related to the surgery.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CycloPen Cyclodialysis System in conjunction with cataract surgery CycloPen Cyclodialysis System Ophthalmic surgical intervention with the CycloPen Cyclodialysis System in conjunction with cataract surgery CycloPen Cyclodialysis System in standalone surgery CycloPen Cyclodialysis System Ophthalmic surgical intervention with the CycloPen Cyclodialysis System
- Primary Outcome Measures
Name Time Method Percent of eyes with intraocular pressure (IOP) reduction ≥ 20% in comparison with baseline 12 months postoperative Intraocular pressure (IOP) is at least 20% lower than before surgery without additional ocular hypotensive medications or IOP-lowering surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
CREST Site 14
🇺🇸New Brunswick, New Jersey, United States
CREST Site 15
🇺🇸New York, New York, United States
CREST Site 12
🇺🇸Chevy Chase, Maryland, United States
CREST Site 13
🇺🇸Rockville, Maryland, United States
CREST Site 16
🇺🇸Las Vegas, Nevada, United States
CREST Site 09
🇺🇸Fort Worth, Texas, United States
CREST Site 301
🇵🇦Ciudad de Panamá, Panama
CREST Site 05
🇺🇸Newport Beach, California, United States
CREST Site 03
🇺🇸Cape Coral, Florida, United States
CREST Site 10
🇺🇸DeLand, Florida, United States
CREST Site 06
🇺🇸Fort Myers, Florida, United States
CREST Site 07
🇺🇸Atlanta, Georgia, United States
CREST Site 01
🇺🇸Fort Washington, Pennsylvania, United States
CREST Site 04
🇺🇸Crossville, Tennessee, United States
CREST Site 11
🇺🇸Salt Lake City, Utah, United States