ClinicalTrials.gg
Active, not recruitingNCT06615661CIRCLEUpdated Jul 21, 2026

A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma

An observational study in Primary Open Angle Glaucoma (POAG), sponsored by Iantrek, Inc.. Active, not recruiting at 6 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Iantrek, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
22 Years and older
Sex
All
01

Study summary

This study enrolls adults with primary open angle glaucoma (POAG) who underwent goniotomy intraocular pressure (IOP)-lowering surgery with the C-Rex Instrument. Patients are consented prior to surgery and followed for 12 months postoperatively. Data regarding IOP, use of glaucoma medications, and any device-related complications are collected during the study time period.

Read the detailed description

This a multicenter, observational real-world evidence study of eligible adults with primary open angle glaucoma (POAG) in whom ab-interno goniotomy surgery with the C-Rex Instrument was performed.

Data is collected from the preoperative visit(s) that directly preceded the surgery, the surgical procedure, and post-surgical visits through 12 months postoperatively.

Specific data collected includes C-Rex Instrument goniotomy surgical details, preoperative and postoperative IOP and use of ocular hypotensive medications, and device-related safety events.

02

Conditions studied

  • Primary Open Angle Glaucoma (POAG)

Keywords

  • Ocular Hypertension
  • Eye Diseases
  • Glaucoma
  • Goniotomy
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 enrollment of 100 is close to 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.

04

Who can participate

Ages eligible
22 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 C-Rex Instrument to perform ab-interno goniotomy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary open angle glaucoma
  • Goniotomy surgery performed using the C-Rex Instrument

Exclusion criteria

Exclusion Criteria:

  • History of intraocular surgery within 8 weeks prior to C-Rex surgery
  • Preoperative IOP higher than 33 mmHg
  • Presence of a glaucoma type other than POAG
  • Presence of intraocular pathology other than cataract or glaucoma
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • C-Rex surgery - combination

    C-Rex surgery combined with cataract extraction/intraocular lens (IOL) implantation

    Device: C-Rex Instrument

  • C-Rex surgery - standalone

    C-Rex surgery as a standalone intervention

    Device: C-Rex Instrument

Interventions

  • DeviceC-Rex Instrument

    The C-Rex Instrument is a manual ophthalmic surgical instrument used for ab interno goniotomy and inner wall trabeculotomy.

06

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 month postoperative

07

Study locations

6 sites
  • CIRCLE Site 32
    Cape Coral, Florida 33904, United States
  • CIRCLE Site 10
    DeLand, Florida 32720, United States
  • CIRCLE Site 07
    Atlanta, Georgia 30342, United States
  • CIRCLE Site 30
    Brentwood, New York 11717, United States
  • CIRCLE Site 31
    Rockville Centre, New York 11570, United States
  • CIRCLE Site 04
    Crossville, Tennessee 38555, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06615661
Lead sponsor
Iantrek, Inc.
Responsible party
Sponsor
First posted
Sep 26, 2024
Start date
Aug 14, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jul 21, 2026

Study contacts

Tsontcho Ianchulev, MD, MPH
study director · CMO

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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Discussion

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