Open-angle Glaucoma (OAG)CREST-XTNCT07480343
5-Year Postoperative Outcomes of Patients Who Completed the CREST Study
An observational study of Open-angle Glaucoma (OAG), run by Iantrek, Inc. at 10 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Open-angle Glaucoma (OAG)
- What is being tested?
- CycloPen Micro-Interventional Cyclodialysis System and CycloPen Micro-Interventional Cyclodialysis System Post Cataract
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 10 sitesUnited States
- Study dates
- 15 Sep 2025to Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants are undergoing treatment for glaucoma at medical clinics located in the United States
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites
CREST-XT Site 07
Atlanta, Georgia, 30342
CREST-XT Site 03
Cape Coral, Florida, 33904
CREST-XT Site 12
Chevy Chase, Maryland, 20815
CREST-XT Site 04
Crossville, Tennessee, 38555
CREST-XT Site 10
DeLand, Florida, 32720
CREST-XT Site 01
Fort Washington, Pennsylvania, 19034
CREST-XT Site 16
Las Vegas, Nevada, 89145
CREST-XT Site 05
Newport Beach, California, 92663
CREST-XT Site 13
Rockville, Maryland, 20852
CREST-XT Site 11
Salt Lake City, Utah, 84132
About this study
Official 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)
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).
Read the 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
- Open-angle Glaucoma (OAG)
- Being tested
- CycloPen Micro-Interventional Cyclodialysis System, CycloPen Micro-Interventional Cyclodialysis System Post Cataract
- Keywords
- Bio-interventional cyclodialysis, AlloFlo, CycloPen
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CycloPen Micro-Interventional Cyclodialysis SystemProcedure or 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.
CycloPen Micro-Interventional Cyclodialysis System Post CataractProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Bio-reinforced Cyclodialysis in conjunction with cataract surgery | Cataract surgery is performed, then followed by bio-reinforced cyclodialysis using the CycloPen Cyclodialysis System Receives: Procedure: CycloPen Micro-Interventional Cyclodialysis System Post Cataract | |
| Bio-reinforced Cyclodialysis alone | Bio-reinforced cyclodialysis is performed using the CycloPen Cyclodialysis System Receives: Procedure: CycloPen Micro-Interventional Cyclodialysis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in intraocular pressure (IOP)
Mean change in intraocular pressure (IOP) measured using tonometry
Measured: From before bio-interventional cyclodialysis to 60 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start15 Sep 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-angle Glaucoma (OAG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Iantrek, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tsontcho Ianchulev, MD, MPH, Study director, Iantrek, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480343
- Sponsor's protocol ID
- ITR-CYC-042
- Acronym
- CREST-XT
- Status last verified
- Jul 2026
- First submitted
- 29 Dec 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07480343
- Acronym / sponsor ID
- CREST-XT / ITR-CYC-042
- Conditions
- Open-angle Glaucoma (OAG)
- Keywords
- Bio-interventional cyclodialysis, AlloFlo, CycloPen
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Iantrek, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-reinforced Cyclodialysis in conjunction with cataract surgery | – | Procedure: CycloPen Micro-Interventional Cyclodialysis System Post CataractCataract surgery is performed, then followed by bio-reinforced cyclodialysis using the CycloPen Cyclodialysis System |
| Bio-reinforced Cyclodialysis alone | – | Procedure: CycloPen Micro-Interventional Cyclodialysis SystemBio-reinforced cyclodialysis is performed using the CycloPen Cyclodialysis System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants are undergoing treatment for glaucoma at medical clinics located in the United States
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CycloPen Micro-Interventional Cyclodialysis SystemThe 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 or surgery | Bio-reinforced Cyclodialysis alone |
| CycloPen Micro-Interventional Cyclodialysis System Post CataractAfter 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. | Procedure or surgery | Bio-reinforced Cyclodialysis in conjunction with cataract surgery |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tsontcho Ianchulev, MD, MPH study director
Iantrek, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open-angle Glaucoma (OAG), run by Iantrek, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in intraocular pressure (IOP) (time frame: From before bio-interventional cyclodialysis to 60 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.