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

Iantrek

Status: Invitation-only

Conditions: Open Angle Glaucoma

Treatments: Device: CycloPen Cyclodialysis System

Study type: Observational

Funder types: Industry

Identifiers

NCT05506423

ITR-CYC-041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

300 participants in 2 patient groups

CycloPen Cyclodialysis System in conjunction with cataract surgery

Description:

Ophthalmic surgical intervention with the CycloPen Cyclodialysis System in conjunction with cataract surgery

Treatment:

Device: CycloPen Cyclodialysis System

CycloPen Cyclodialysis System in standalone surgery

Description:

Ophthalmic surgical intervention with the CycloPen Cyclodialysis System

Treatment:

Device: CycloPen Cyclodialysis System