300 Participants Needed

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

(CREST Trial)

Recruiting at 15 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Iantrek, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial involves adults with open angle glaucoma who had surgery to lower eye pressure. The study will follow these patients for two years to collect data on eye pressure, medication use, and any side effects.

Research Team

GK

Gautam Kamthan, MD

Principal Investigator

Iantrek, Inc.

Eligibility Criteria

Inclusion Criteria

You have an intraocular pressure of less than 31 mmHg prior to surgery.
You have used ≤ 3 ocular hypotensive medications prior to surgery.
You have undergone an IOP-lowering surgical procedure using the CycloPen System.

Exclusion Criteria

You have a narrow angle in your eye.
Clinically significant corneal abnormality or concurrent intraocular pathology
Previous trabeculectomy or tube-shunt surgery, or previous iridotomy
See 1 more

Treatment Details

Interventions

  • CycloPen Cyclodialysis System
Participant Groups
2Treatment groups
Experimental Treatment
Group I: CycloPen Cyclodialysis System in standalone surgeryExperimental Treatment1 Intervention
Ophthalmic surgical intervention with the CycloPen Cyclodialysis System
Group II: CycloPen Cyclodialysis System in conjunction with cataract surgeryExperimental Treatment1 Intervention
Ophthalmic surgical intervention with the CycloPen Cyclodialysis System in conjunction with cataract surgery

Find a Clinic Near You

Who Is Running the Clinical Trial?

Iantrek, Inc.

Lead Sponsor

Trials
2
Recruited
500+