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

Part of paid clinical trials in Newport Beach, California.

Sponsor
Iantrek, Inc.
Study ID
NCT05506423
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CycloPen Cyclodialysis System — DEVICE
    The CycloPen Micro-Interventional Cyclodialysis System is used to create and cyclodialysis cleft and deliver allograft scleral tissue and/or viscous material to reinforce and maintain the cleft postoperatively.

Study Details

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.

Key Dates

Start date
Aug 17, 2022
Status verified
Dec 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: CycloPen Cyclodialysis System in conjunction with cataract surgery
    Ophthalmic surgical intervention with the CycloPen Cyclodialysis System in conjunction with cataract surgery
  • Arm: CycloPen Cyclodialysis System in standalone surgery
    Ophthalmic surgical intervention with the CycloPen Cyclodialysis System

Primary Outcome Measure

Percent of eyes with intraocular pressure (IOP) reduction ≥ 20% in comparison with baseline [ Time Frame: 12 months postoperative ]

Locations (15)

FacilityCityStateZIPSite coordinators
CREST Site 05Newport BeachCalifornia92663-
CREST Site 03Cape CoralFlorida33904-
CREST Site 10DeLandFlorida32720-
CREST Site 06Fort MyersFlorida33912-
CREST Site 07AtlantaGeorgia30342-
CREST Site 12Chevy ChaseMaryland20815-
CREST Site 13RockvilleMaryland20852-
CREST Site 16Las VegasNevada89145-
CREST Site 14New BrunswickNew Jersey07728-
CREST Site 15New YorkNew York10034-
CREST Site 17WilliamsvilleNew York14221-
CREST Site 01Fort WashingtonPennsylvania19034-
CREST Site 04CrossvilleTennessee38555-
CREST Site 09Fort WorthTexas76102-
CREST Site 11Salt Lake CityUtah84132-

Find similar trials in Newport Beach, CA

By condition
Glaucoma
By specialty
Ophthalmology
By research site
CREST· Newport Beach, CACREST· Cape Coral, FLCREST· DeLand, FLCREST· Fort Myers, FLCREST· Atlanta, GACREST· Chevy Chase, MD

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