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Enrolling by Invitation

NCT Number: NCT07480343

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

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).

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Key information

Conditions

Open-angle Glaucoma (OAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

CREST-XT Site 05, Newport Beach, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Mean change in intraocular pressure (IOP)

    Time frame: From before bio-interventional cyclodialysis to 60 months after surgery

    Mean change in intraocular pressure (IOP) measured using tonometry

Other outcomes

  1. Mean change in number of IOP-lowering medications used

    Time frame: From before bio-interventional cyclodialysis to 60 months after surgery

    Mean change in the number of IOP-lowering medications used

  2. Percent change in intraocular pressure (IOP)

    Time frame: From before bio-interventional cyclodialysis to 60 months after surgery

    Mean percent change in IOP in comparison with baseline (prior to surgery), while using the same or fewer IOP-lowering medications and without additional IOP-lowering surgical or laser procedures

  3. Percent of eyes with ≥ 20% decrease in intraocular pressure (IOP)

    Time frame: From before bio-interventional cyclodialysis to 60 months after surgery

    Proportion of eyes with postoperative IOP ≥ 20% lower than baseline (prior to surgery), while using the same or fewer IOP-lowering medications and without additional IOP-lowering surgical or laser procedures

Sponsors and collaborators

Lead sponsor

Iantrek, Inc.

Industry

Registry information

Official study 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)

Acronym: CREST-XT

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Mar 18, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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