NCT07480343

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
52mo left

Started Sep 2025

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Sep 2025Dec 2030

Study Start

First participant enrolled

September 15, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

5.2 years

First QC Date

December 29, 2025

Last Update Submit

July 18, 2026

Conditions

Open-angle Glaucoma (OAG)

Keywords

Bio-interventional cyclodialysisAlloFloCycloPen

Outcome Measures

Primary Outcomes (1)

  • Mean change in intraocular pressure (IOP)

    Mean change in intraocular pressure (IOP) measured using tonometry

    From before bio-interventional cyclodialysis to 60 months after surgery

Other Outcomes (3)

  • Mean change in number of IOP-lowering medications used

    From before bio-interventional cyclodialysis to 60 months after surgery

  • Percent change in intraocular pressure (IOP)

    From before bio-interventional cyclodialysis to 60 months after surgery

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

    From before bio-interventional cyclodialysis to 60 months after surgery

Study Arms (2)

Bio-reinforced Cyclodialysis in conjunction with cataract surgery

Cataract surgery is performed, then followed by bio-reinforced cyclodialysis using the CycloPen Cyclodialysis System

Procedure: CycloPen Micro-Interventional Cyclodialysis System Post Cataract

Bio-reinforced Cyclodialysis alone

Bio-reinforced cyclodialysis is performed using the CycloPen Cyclodialysis System

Procedure: CycloPen Micro-Interventional Cyclodialysis System

Interventions

CycloPen Micro-Interventional Cyclodialysis SystemPROCEDURE

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.

Bio-reinforced Cyclodialysis alone
CycloPen Micro-Interventional Cyclodialysis System Post CataractPROCEDURE

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.

Bio-reinforced Cyclodialysis in conjunction with cataract surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants are undergoing treatment for glaucoma at medical clinics located in the United States

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CREST-XT Site 05

Newport Beach, California, 92663, United States

Location

CREST-XT Site 03

Cape Coral, Florida, 33904, United States

Location

CREST-XT Site 10

DeLand, Florida, 32720, United States

Location

CREST-XT Site 07

Atlanta, Georgia, 30342, United States

Location

CREST-XT Site 12

Chevy Chase, Maryland, 20815, United States

Location

CREST-XT Site 13

Rockville, Maryland, 20852, United States

Location

CREST-XT Site 16

Las Vegas, Nevada, 89145, United States

Location

CREST-XT Site 01

Fort Washington, Pennsylvania, 19034, United States

Location

CREST-XT Site 04

Crossville, Tennessee, 38555, United States

Location

CREST-XT Site 11

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Tsontcho Ianchulev, MD, MPH

    Iantrek, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2025

First Posted

March 18, 2026

Study Start

September 15, 2025

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(10)