5-Year Postoperative Outcomes of Patients Who Completed the CREST Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CycloPen Micro-Interventional Cyclodialysis System, CycloPen Micro-Interventional Cyclodialysis System Post Cataract.
- Who it may be relevant to
- Registry conditions: Open-angle Glaucoma (OAG). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
FIVE-YEAR POSTOPERATIVE OUTCOMES IN PATIENTS WITH OPEN-ANGLE GLAUCOMA WHO UNDERWENT BIO-INTERVENTIONAL UVEOSCLERAL OUTFLOW ENHANCEMENT SURGERY: LONG-TERM OBSERVATIONAL FOLLOW-UP FROM THE CREST STUDY (THE CREST-XT STUDY)
Overview
This study is designed to collect clinical data at 3, 4, and 5 years postoperatively for participants who completed the CREST Study without having secondary IOP-lowering surgery in the study eye(s).
Detailed description
This is a multicenter, prospective, observational study following eligible participants who completed the CREST Study. Participants who consent to participate will have clinical data gathered from annual ophthalmic examinations through 60 months after CycloPen System surgery for analysis of long-term outcomes. As an observational study, examinations at each visit are performed per the investigator's standard of care.
Interventions
- Procedure CycloPen Micro-Interventional 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. - Procedure CycloPen Micro-Interventional Cyclodialysis System Post Cataract
After cataract surgery, 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.
Primary outcome measures
- Mean change in intraocular pressure (IOP) [Time frame: From before bio-interventional cyclodialysis to 60 months after surgery]
Eligibility criteria
Inclusion criteria
- Diagnosis of open-angle glaucoma (OAG) in the study eye(s), including pigmentary and pseudoexfoliative glaucoma, at the time of CREST enrollment
- Completed participation in CREST
- Provide signed written consent using the Institutional Review Board (IRB)/Ethics Committee (EC) approved study-specific informed consent form (ICF)
- Ability, comprehension, and willingness to follow study instructions
Exclusion criteria
- Systemic disease that, in the opinion of the Investigator, would put participant's health at risk and/or prevent completion of required study visits
- Early termination from CREST
- Secondary surgical intervention for long-term IOP control in the study eye(s)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 10 centers
- CREST-XT Site 05 — Newport Beach
- CREST-XT Site 03 — Cape Coral
- CREST-XT Site 10 — DeLand
- CREST-XT Site 07 — Atlanta
- CREST-XT Site 12 — Chevy Chase
- CREST-XT Site 13 — Rockville
- CREST-XT Site 16 — Las Vegas
- CREST-XT Site 01 — Fort Washington
- … and 2 more centers
Identifiers
NCT: NCT07480343 · ITR-CYC-042