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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07480343

Acronym

CREST-XT

Enrollment

250

Registered

2026-03-18

Start date

2025-09-15

Completion date

2030-12-01

Last updated

2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-angle Glaucoma (OAG)

Keywords

Bio-interventional cyclodialysis, AlloFlo, CycloPen

Brief 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.

Interventions

PROCEDURECycloPen 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.

PROCEDURECycloPen 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

1. Diagnosis of open-angle glaucoma (OAG) in the study eye(s), including pigmentary and pseudoexfoliative glaucoma, at the time of CREST enrollment 2. Completed participation in CREST 3. Provide signed written consent using the Institutional Review Board (IRB)/Ethics Committee (EC) approved study-specific informed consent form (ICF) 4. Ability, comprehension, and willingness to follow study instructions

Exclusion criteria

1. Systemic disease that, in the opinion of the Investigator, would put participant's health at risk and/or prevent completion of required study visits 2. Early termination from CREST 3. Secondary surgical intervention for long-term IOP control in the study eye(s)

Design outcomes

Primary

Measure	Time frame	Description
Mean change in intraocular pressure (IOP)	From before bio-interventional cyclodialysis to 60 months after surgery	Mean change in intraocular pressure (IOP) measured using tonometry

Countries

United States

Contacts

STUDY_DIRECTORTsontcho Ianchulev, MD, MPH

Iantrek, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026