Study of the CycloPen Micro-Interventional System and Long-Term Clinical Outcomes
CREST
An Observational Registry Study of Safety and Effectiveness Outcomes Through 24 Months Postoperatively Following CycloPen™ Micro-Interventional Cyclodialysis System Procedures in Patients With Open Angle Glaucoma
1 other identifier
observational
300
2 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2022
CompletedStudy Start
First participant enrolled
August 17, 2022
CompletedFirst Posted
Study publicly available on registry
August 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
December 23, 2025
December 1, 2025
4 years
August 16, 2022
December 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of eyes with intraocular pressure (IOP) reduction ≥ 20% in comparison with baseline
Intraocular pressure (IOP) is at least 20% lower than before surgery without additional ocular hypotensive medications or IOP-lowering surgery
12 months postoperative
Study Arms (2)
CycloPen Cyclodialysis System in conjunction with cataract surgery
Ophthalmic surgical intervention with the CycloPen Cyclodialysis System in conjunction with cataract surgery
CycloPen Cyclodialysis System in standalone surgery
Ophthalmic surgical intervention with the CycloPen Cyclodialysis System
Interventions
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
Eligible participants who underwent IOP-lowering surgical procedures using the CycloPen Micro-Interventional System for uveoscleral outflow enhancement
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Iantrek, Inc.lead
Study Sites (16)
CREST Site 05
Newport Beach, California, 92663, United States
CREST Site 03
Cape Coral, Florida, 33904, United States
CREST Site 10
DeLand, Florida, 32720, United States
CREST Site 06
Fort Myers, Florida, 33912, United States
CREST Site 07
Atlanta, Georgia, 30342, United States
CREST Site 12
Chevy Chase, Maryland, 20815, United States
CREST Site 13
Rockville, Maryland, 20852, United States
CREST Site 16
Las Vegas, Nevada, 89145, United States
CREST Site 14
New Brunswick, New Jersey, 07728, United States
CREST Site 15
New York, New York, 10034, United States
CREST Site 17
Williamsville, New York, 14221, United States
CREST Site 01
Fort Washington, Pennsylvania, 19034, United States
CREST Site 04
Crossville, Tennessee, 38555, United States
CREST Site 09
Fort Worth, Texas, 76102, United States
CREST Site 11
Salt Lake City, Utah, 84132, United States
CREST Site 301
Panama City, Panama
Related Publications (1)
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.
PMID: 40799662DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tsontcho Ianchulev, MD
Iantrek, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2022
First Posted
August 18, 2022
Study Start
August 17, 2022
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2027
Last Updated
December 23, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share