Trials / Enrolling By Invitation
Enrolling By InvitationNCT07480343
5-Year Postoperative Outcomes of Patients Who Completed the CREST Study
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)
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 250 (estimated)
- Sponsor
- Iantrek, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-09-15
- Primary completion
- 2030-12-01
- Completion
- 2030-12-01
- First posted
- 2026-03-18
- Last updated
- 2026-04-01
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07480343. Inclusion in this directory is not an endorsement.