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Active, not recruitingNCT05506423CRESTUpdated Jul 22, 2026

Study of the CycloPen Micro-Interventional System and Long-Term Clinical Outcomes

An observational study in Open Angle Glaucoma, sponsored by Iantrek, Inc.. Active, not recruiting at 16 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Iantrek, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
21 Years and older
Sex
All
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Study 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.

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.

02

Conditions studied

  • Open Angle Glaucoma

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03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's planned enrollment of 300 is above the median of 101 across 184 observational studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Iantrek, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Eligible participants who underwent IOP-lowering surgical procedures using the CycloPen Micro-Interventional System for uveoscleral outflow enhancement

Eligibility criteria

To be included, participants must have:

  1. Open angle glaucoma
  2. IOP-lowering surgical procedure using the CycloPen System

There are no exclusionary criteria.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes

Groups and cohorts

  • CycloPen Cyclodialysis System in conjunction with cataract surgery

    Ophthalmic surgical intervention with the CycloPen Cyclodialysis System in conjunction with cataract surgery

    Device: CycloPen Cyclodialysis System

  • CycloPen Cyclodialysis System in standalone surgery

    Ophthalmic surgical intervention with the CycloPen Cyclodialysis System

    Device: CycloPen Cyclodialysis System

Interventions

  • DeviceCycloPen Cyclodialysis System

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months postoperative

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Study locations

16 sites
  • Visionary Eye Institute
    Newport Beach, California 92663, United States
  • Tyson Eye
    Cape Coral, Florida 33904, United States
  • Central Florida Eye Specialists
    DeLand, Florida 32720, United States
  • Eye Associates of Ft. Myers
    Fort Myers, Florida 33912, United States
  • Omni Eye Services
    Atlanta, Georgia 30342, United States
  • Eye Doctors of Washington
    Chevy Chase, Maryland 20815, United States
  • Visionary Eye Doctors
    Rockville, Maryland 20852, United States
  • Center for Sight
    Las Vegas, Nevada 89145, United States
  • Wilton Center for Advanced Eyecare
    New Brunswick, New Jersey 07728, United States
  • North Manhattan Eye Center
    New York, New York 10034, United States
  • Buffalo Ophthalmology
    Williamsville, New York 14221, United States
  • James S Lewis, MD
    Fort Washington, Pennsylvania 19034, United States
  • Eye Centers of Tennessee
    Crossville, Tennessee 38555, United States
  • Ophthalmology Associates
    Fort Worth, Texas 76102, United States
  • John Moran Eye Center - U of Utah
    Salt Lake City, Utah 84132, United States
  • Panama Eye Center
    Panama City, Panama
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05506423
Lead sponsor
Iantrek, Inc.
Responsible party
Sponsor
First posted
Aug 18, 2022
Start date
Aug 17, 2022
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 22, 2026

Study contacts

Tsontcho Ianchulev, MD,MPH
study chair · Iantrek, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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