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

Study acronym: CREST
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Study sites revised (16)v11
  2. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Primary completion date: Aug 2026 to Dec 2026
    • Study completion date: Aug 2027 to Dec 2027
    v10
  3. Study sites: 15 to 16v9
  4. Primary completion date: Mar 2025 to Aug 2026
    • Study sites: 9 to 15
    • Study completion date: Mar 2026 to Aug 2027
    v8
  5. Primary completion date: Dec 2024 to Mar 2025
    • Study completion date: Dec 2025 to Mar 2026
    • Study sites revised (9)
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary endpoint revised
    • Eligibility criteria expanded, about 8 words
    v6
  2. Enrollment target: 200 to 300v5 Show 6 more changesShow less
    • Study sites: 8 to 9
    • Primary completion date: Aug 2024 to Dec 2024
    • Study completion date: Aug 2025 to Dec 2025
    • Eligibility criteria shortened, about 43 words
    • Study description expanded, about 79 words
    • Study title expanded, about 3 words
  3. Phase: Not applicable to Not specified
    • Primary endpoint revised
    • Study arms: 1 to 2
    • Study title shortened, about 3 words
    v4
  4. Study sites: 5 to 8v3
  5. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Aug 2022 to Aug 17, 2022
    • Site contacts updated at 5 of 5 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05506423
Lead Sponsor Iantrek, Inc.
Conditions
(from sponsor)		 Open Angle Glaucoma
Related terms Glaucoma, Open-Angle
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov