Open Angle GlaucomaCRESTNCT05506423
Study of the CycloPen Micro-Interventional System and Long-Term Clinical Outcomes
An observational study of Open Angle Glaucoma, run by Iantrek, Inc. at 16 sites in 2 countries.
Trial summary
This observational study will enroll adults with open angle glaucoma (OAG) who had surgery to reduce intraocular pressure (IOP) using the CycloPen Micro-Interventional System. Consenting participants will be followed for 24 months after their surgery. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- CycloPen Cyclodialysis System
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 17 Aug 2022to Dec 2027
- How long will I take part?
- 24 Months
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants who underwent IOP-lowering surgical procedures using the CycloPen Micro-Interventional System for uveoscleral outflow enhancement
To be included, participants must have:
- Open angle glaucoma
- IOP-lowering surgical procedure using the CycloPen System
There are no exclusionary criteria.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States15 sites
Omni Eye Services
Atlanta, Georgia, 30342
Tyson Eye
Cape Coral, Florida, 33904
Eye Doctors of Washington
Chevy Chase, Maryland, 20815
Eye Centers of Tennessee
Crossville, Tennessee, 38555
Central Florida Eye Specialists
DeLand, Florida, 32720
Eye Associates of Ft. Myers
Fort Myers, Florida, 33912
James S Lewis, MD
Fort Washington, Pennsylvania, 19034
Ophthalmology Associates
Fort Worth, Texas, 76102
Center for Sight
Las Vegas, Nevada, 89145
Wilton Center for Advanced Eyecare
New Brunswick, New Jersey, 07728
North Manhattan Eye Center
New York, New York, 10034
Visionary Eye Institute
Newport Beach, California, 92663
Visionary Eye Doctors
Rockville, Maryland, 20852
John Moran Eye Center - U of Utah
Salt Lake City, Utah, 84132
Buffalo Ophthalmology
Williamsville, New York, 14221
About this study
Official title: An Observational Registry Study of Safety and Effectiveness Outcomes Through 24 Months Postoperatively Following CycloPen™ Micro-Interventional Cyclodialysis System Procedures in Patients With Open Angle Glaucoma
This observational study will enroll adults with open angle glaucoma (OAG) who had surgery to reduce intraocular pressure (IOP) using the CycloPen Micro-Interventional System. Consenting participants will be followed for 24 months after their surgery.
Data regarding IOP, use of glaucoma medications, and any side effects related to the surgery will be collected from participants' preoperative examination, their surgery, and postoperative examinations.
Read the detailed description
This is a multicenter, observational registry of eligible adults with open angle glaucoma (OAG) in whom IOP-lowering surgery with the CycloPen Micro-Interventional System was performed are consecutively enrolled.
Data will be collected from the preoperative visit(s) that directly preceded surgery, the surgical procedure, and postoperative visits through 24 months after CycloPen System use.
Specific data to be collected includes details of the CycloPen surgical procedure, IOP, use of ocular hypotensive medications, and any side effects related to the surgery.
- Conditions
- Open Angle Glaucoma
- Being tested
- CycloPen Cyclodialysis System
- 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 Cyclodialysis SystemDevice
The CycloPen Micro-Interventional Cyclodialysis System is used to create a cyclodialysis cleft and deliver allograft scleral tissue and/or viscous material within the cleft for endoscleral reinforcement.
| Study group | Role | What they receive |
|---|---|---|
| CycloPen Cyclodialysis System in conjunction with cataract surgery | Ophthalmic surgical intervention with the CycloPen Cyclodialysis System in conjunction with cataract surgery Receives: Device: CycloPen Cyclodialysis System | |
| CycloPen Cyclodialysis System in standalone surgery | Ophthalmic surgical intervention with the CycloPen Cyclodialysis System Receives: Device: CycloPen Cyclodialysis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of eyes with intraocular pressure (IOP) reduction ≥ 20% in comparison with baseline
Intraocular pressure (IOP) is at least 20% lower than before surgery without additional ocular hypotensive medications or IOP-lowering surgery
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start17 Aug 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Angle GlaucomaStudies 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
- 300 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Iantrek, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tsontcho Ianchulev, MD,MPH, Study chair, Iantrek, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506423
- Sponsor's protocol ID
- ITR-CYC-041
- Acronym
- CREST
- Status last verified
- Jul 2026
- First submitted
- 16 Aug 2022
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Barber K, Flowers B, Patterson M, Vera L, Ianchulev T, Ahmed II. Bio-interventional uveoscleral outflow enhancement in patients with medically uncontrolled primary open-angle glaucoma: 1-year results of allograft-reinforced cyclodialysis. Ther Adv Ophthalmol. 2025 Aug 11;17:25158414251362010. doi: 10.1177/25158414251362010. eCollection 2025 Jan-Dec.
PubMed 40799662
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Registry Study of Safety and Effectiveness Outcomes Through 24 Months Postoperatively Following CycloPen™ Micro-Interventional Cyclodialysis System Procedures in Patients With Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT05506423
- Acronym / sponsor ID
- CREST / ITR-CYC-041
- Conditions
- Open Angle Glaucoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Iantrek, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Aug 2022 (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 observational study will enroll adults with open angle glaucoma (OAG) who had surgery to reduce intraocular pressure (IOP) using the CycloPen Micro-Interventional System. Consenting participants will be followed for 24 months after their surgery.
Data regarding IOP, use of glaucoma medications, and any side effects related to the surgery will be collected from participants' preoperative examination, their surgery, and postoperative examinations.
Detailed description
This is a multicenter, observational registry of eligible adults with open angle glaucoma (OAG) in whom IOP-lowering surgery with the CycloPen Micro-Interventional System was performed are consecutively enrolled.
Data will be collected from the preoperative visit(s) that directly preceded surgery, the surgical procedure, and postoperative visits through 24 months after CycloPen System use.
Specific data to be collected includes details of the CycloPen surgical procedure, IOP, use of ocular hypotensive medications, and any side effects related to the surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CycloPen Cyclodialysis System in conjunction with cataract surgery | – | Device: CycloPen Cyclodialysis SystemOphthalmic surgical intervention with the CycloPen Cyclodialysis System in conjunction with cataract surgery |
| CycloPen Cyclodialysis System in standalone surgery | – | Device: CycloPen Cyclodialysis SystemOphthalmic surgical intervention with the CycloPen Cyclodialysis System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants who underwent IOP-lowering surgical procedures using the CycloPen Micro-Interventional System for uveoscleral outflow enhancement
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 Cyclodialysis SystemThe CycloPen Micro-Interventional Cyclodialysis System is used to create a cyclodialysis cleft and deliver allograft scleral tissue and/or viscous material within the cleft for endoscleral reinforcement. | Device | CycloPen Cyclodialysis System in conjunction with cataract surgery, CycloPen Cyclodialysis System in standalone surgery |
Primary outcome
Percent of eyes with intraocular pressure (IOP) reduction ≥ 20% in comparison with baseline
Time frame: 12 months postoperative
Intraocular pressure (IOP) is at least 20% lower than before surgery without additional ocular hypotensive medications or IOP-lowering surgery
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 22 Jul 2026.
- Derived from this study: PubMed 40799662Barber K, Flowers B, Patterson M, Vera L, Ianchulev T, Ahmed II. Bio-interventional uveoscleral outflow enhancement in patients with medically uncontrolled primary open-angle glaucoma: 1-year results of allograft-reinforced cyclodialysis. Ther Adv Ophthalmol. 2025 Aug 11;17:25158414251362010. doi: 10.1177/25158414251362010. eCollection 2025 Jan-Dec.
- 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. This study is not recruiting at the moment.
Tsontcho Ianchulev, MD,MPH study chair
Iantrek, Inc.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle Glaucoma, run by Iantrek, Inc. at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 22 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 16 sites in United States, Panama. 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?
Percent of eyes with intraocular pressure (IOP) reduction ≥ 20% in comparison with baseline (time frame: 12 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05506423, which also lists 1 linked publication.
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 22 Jul 2026.