Primary Open Angle Glaucoma (POAG)CIRCLENCT06615661
A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma
An observational study of Primary Open Angle Glaucoma (POAG), run by Iantrek, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma (POAG)
- What is being tested?
- C-Rex Instrument
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Aug 2024to Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants who underwent IOP-lowering surgical procedures using the C-Rex Instrument to perform ab-interno goniotomy
Who may be able to join
- Primary open angle glaucoma
- Goniotomy surgery performed using the C-Rex Instrument
Who cannot join
- 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 clinically significant intraocular pathology other than cataract or glaucoma
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
CIRCLE Site 07
Atlanta, Georgia, 30342
CIRCLE Site 30
Brentwood, New York, 11717
CIRCLE Site 32
Cape Coral, Florida, 33904
CIRCLE Site 04
Crossville, Tennessee, 38555
CIRCLE Site 10
DeLand, Florida, 32720
CIRCLE Site 31
Rockville Centre, New York, 11570
About this study
Official title: An Observational Real-World Evidence Study of Ab-Interno Goniotomy Performed Using the C-Rex Instrument in Patients With Primary Open Angle Glaucoma
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.
- Conditions
- Primary Open Angle Glaucoma (POAG)
- Being tested
- C-Rex Instrument
- Keywords
- Ocular Hypertension, Eye Diseases, Glaucoma, Goniotomy
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Eye Diseases, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Rex InstrumentDevice
The C-Rex Instrument is a manual ophthalmic surgical instrument used for ab interno goniotomy and inner wall trabeculotomy.
| Study group | Role | What they receive |
|---|---|---|
| C-Rex surgery - combination | C-Rex surgery combined with cataract extraction/intraocular lens (IOL) implantation Receives: Device: C-Rex Instrument | |
| C-Rex surgery - standalone | C-Rex surgery as a standalone intervention Receives: Device: C-Rex Instrument |
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 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start14 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle Glaucoma (POAG)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
- 100 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Iantrek, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tsontcho Ianchulev, MD, MPH, Study director, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615661
- Sponsor's protocol ID
- ITR-GON-041
- Acronym
- CIRCLE
- Status last verified
- Jul 2026
- First submitted
- 24 Sep 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No