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CREST: Registry Study of CycloPen System Postoperative Outcomes Through 24 Months

Sponsor
Iantrek, Inc. (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05506423
Collaborator
(none)
200
Enrollment
5
Locations
1
Arm
35.5
Anticipated Duration (Months)
40
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The registry will consecutively enroll adults with open angle glaucoma (OAG) who have undergone intraocular pressure-lowering surgery using the CycloPen System. Data will be retrospectively collected from participants' preoperative ophthalmic examination(s) and the surgical procedure in which the CycloPen System was used. Prospectively, data will be collected from ophthalmic examinations through 24 months postoperatively.

Condition or Disease Intervention/Treatment Phase
  • Device: CycloPen Cyclodialysis System
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Registry Study of Safety and Effectiveness Outcomes Through 24 Months Postoperatively Following CycloPen™ Cyclodialysis System Procedures in Patients With Open Angle Glaucoma
Actual Study Start Date :
Aug 17, 2022
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: CycloPen

Participant underwent intraocular pressure lowering surgery using the CycloPen Cyclodialysis System

Device: CycloPen Cyclodialysis System
The CycloPen Cyclodialysis System is a manual surgical instrument set for the ab-interno construction or modification of a cyclodialysis cleft via controlled dissection of a plane in the supraciliary space and delivery of viscous or non-viscous materials to facilitate maintenance of the cleft.

Outcome Measures

Primary Outcome Measures

  1. Percent of eyes with IOP reduction ≥ 20% [Baseline, 12 months postoperative]

    Intraocular pressure is at least 20% lower than before surgery without additional ocular hypotensive medications or IOP-lowering surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Underwent an IOP-lowering surgical procedure using the CycloPen System

  • OAG, with IOP < 31 mmHg prior to surgery

  • Use of ≤ 3 ocular hypotensive medications prior to surgery

Exclusion Criteria:

  • Clinically significant corneal abnormality or concurrent intraocular pathology

  • Previous trabeculectomy or tube-shunt surgery, or previous iridotomy

  • Axial length > 26.0 mm

  • Narrow anatomic angle

Contacts and Locations

Locations

Site City State Country Postal Code
1 CREST Site 03 Cape Coral Florida United States 33904
2 CREST Site 06 Fort Myers Florida United States 33912
3 CREST Site 01 Fort Washington Pennsylvania United States 19034
4 CREST Site 04 Crossville Tennessee United States 38555
5 CREST Site 02 Kenosha Wisconsin United States 53142

Sponsors and Collaborators

  • Iantrek, Inc.

Investigators

  • Study Director: Gautam Kamthan, MD, Iantrek, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Iantrek, Inc.
ClinicalTrials.gov Identifier:
NCT05506423
Other Study ID Numbers:
  • ITR-CYC-041
First Posted:
Aug 18, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle

Study Results

No Results Posted as of Aug 22, 2022