Clinical trial NCT05506423: Study of the CycloPen Micro-Interventional System and Long-Term Clinical Outcomes
Official title: An Observational Registry Study of Safety and Effectiveness Outcomes Through 24 Months Postoperatively Following CycloPen™ Micro-Interventional Cyclodialysis System Procedures in Patients With Open Angle Glaucoma
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Open Angle Glaucoma
Lead sponsor: Iantrek, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-18
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

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.

Primary outcomes:
measure: Percent of eyes with intraocular pressure (IOP) reduction ≥ 20% in comparison with baseline
timeFrame: 12 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: CREST Site 05
state: California
city: Cape Coral
country: United States
facility: CREST Site 03
state: Florida
city: DeLand
country: United States
facility: CREST Site 10
state: Florida
city: Fort Myers
country: United States
facility: CREST Site 06
state: Florida
city: Atlanta
country: United States
facility: CREST Site 07
state: Georgia
city: Chevy Chase
country: United States
facility: CREST Site 12
state: Maryland
city: Rockville
country: United States
facility: CREST Site 13
state: Maryland
city: Las Vegas
country: United States
facility: CREST Site 16
state: Nevada
city: New Brunswick
country: United States
facility: CREST Site 14
state: New Jersey
city: New York
country: United States
facility: CREST Site 15
state: New York
city: Fort Washington
country: United States
facility: CREST Site 01
state: Pennsylvania
city: Crossville
country: United States
facility: CREST Site 04
state: Tennessee
city: Fort Worth
country: United States
facility: CREST Site 09
state: Texas
city: Salt Lake City
country: United States
facility: CREST Site 11
state: Utah
city: Ciudad de Panamá
country: Panama
facility: CREST Site 301
Study officials:
affiliation: Iantrek, Inc.
name: Gautam Kamthan, MD
role: STUDY_DIRECTOR
References: