5-Year Postoperative Outcomes of Patients Who Completed the CREST Study

Part of paid clinical trials in Newport Beach, California.

Sponsor
Iantrek, Inc.
Study ID
NCT07480343
Status
Enrolling By Invitation

Conditions

  • Open-angle Glaucoma (OAG)

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • CycloPen Micro-Interventional Cyclodialysis System — PROCEDURE
    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 Micro-Interventional Cyclodialysis System Post Cataract — PROCEDURE
    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.

Study Details

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).

Key Dates

Start date
Sep 15, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Bio-reinforced Cyclodialysis in conjunction with cataract surgery
    Cataract surgery is performed, then followed by bio-reinforced cyclodialysis using the CycloPen Cyclodialysis System
  • Arm: Bio-reinforced Cyclodialysis alone
    Bio-reinforced cyclodialysis is performed using the CycloPen Cyclodialysis System

Primary Outcome Measure

Mean change in intraocular pressure (IOP) [ Time Frame: From before bio-interventional cyclodialysis to 60 months after surgery ]

Locations (10)

FacilityCityStateZIPSite coordinators
CREST-XT Site 05Newport BeachCalifornia92663-
CREST-XT Site 03Cape CoralFlorida33904-
CREST-XT Site 07AtlantaGeorgia30342-
CREST-XT Site 12Chevy ChaseMaryland20815-
CREST-XT Site 13RockvilleMaryland20852-
CREST-XT Site 16Las VegasNevada89145-
CREST-XT Site 15New YorkNew York10034-
CREST-XT Site 01Fort WashingtonPennsylvania19034-
CREST-XT Site 04CrossvilleTennessee38555-
CREST-XT Site 11Salt Lake CityUtah84132-

Find similar trials in Newport Beach, CA

By research site
CREST-XT· Newport Beach, CACREST-XT· Cape Coral, FLCREST-XT· Atlanta, GACREST-XT· Chevy Chase, MDCREST-XT· Rockville, MDCREST-XT· Las Vegas, NV

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