Study of the CycloPen Micro-Interventional System and Long-Term Clinical Outcomes
NCT ID: NCT05506423
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
300 participants
OBSERVATIONAL
2022-08-17
2027-08-31
Brief Summary
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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
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CycloPen Cyclodialysis System in conjunction with cataract surgery
Ophthalmic surgical intervention with the CycloPen Cyclodialysis System in conjunction with cataract surgery
CycloPen Cyclodialysis System
The CycloPen Micro-Interventional Cyclodialysis System is used to create and cyclodialysis cleft and deliver allograft scleral tissue and/or viscous material to reinforce and maintain the cleft postoperatively.
CycloPen Cyclodialysis System in standalone surgery
Ophthalmic surgical intervention with the CycloPen Cyclodialysis System
CycloPen Cyclodialysis System
The CycloPen Micro-Interventional Cyclodialysis System is used to create and cyclodialysis cleft and deliver allograft scleral tissue and/or viscous material to reinforce and maintain the cleft postoperatively.
Interventions
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CycloPen Cyclodialysis System
The CycloPen Micro-Interventional Cyclodialysis System is used to create and cyclodialysis cleft and deliver allograft scleral tissue and/or viscous material to reinforce and maintain the cleft postoperatively.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
21 Years
ALL
No
Sponsors
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Iantrek, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tsontcho Ianchulev, MD
Role: STUDY_CHAIR
Iantrek, Inc.
Locations
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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 12
Chevy Chase, Maryland, United States
CREST Site 13
Rockville, Maryland, United States
CREST Site 16
Las Vegas, Nevada, United States
CREST Site 14
New Brunswick, New Jersey, United States
CREST Site 15
New York, New York, United States
CREST Site 17
Williamsville, New York, United States
CREST Site 01
Fort Washington, Pennsylvania, United States
CREST Site 04
Crossville, Tennessee, United States
CREST Site 09
Fort Worth, Texas, United States
CREST Site 11
Salt Lake City, Utah, United States
CREST Site 301
Panama City, , Panama
Countries
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References
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Barber K, Flowers B, Patterson M, Vera L, Ianchulev T, Ahmed II. Bio-interventional uveoscleral outflow enhancement in patients with medically uncontrolled primary open-angle glaucoma: 1-year results of allograft-reinforced cyclodialysis. Ther Adv Ophthalmol. 2025 Aug 11;17:25158414251362010. doi: 10.1177/25158414251362010. eCollection 2025 Jan-Dec.
Other Identifiers
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ITR-CYC-041
Identifier Type: -
Identifier Source: org_study_id