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The Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study

Study acronym: V-CHECK
StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated October 2, 2025 (before its estimated March 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Sep 30, 2024 to Mar 30, 2026
    • Study completion date: Sep 30, 2025 to Sep 30, 2026
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2023 to Dec 1, 2023
    • Site details revised at 12 of 12 sites
    v4
  3. Start date: Sep 1, 2023 to Nov 1, 2023v3
  4. Primary endpoint revisedv2 Show 5 more changesShow less
    • Enrollment target: 100 to 135
    • Study sites: 1 to 12
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints revised (6)
    • Study description expanded, about 31 words
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this international cohort study is to validate a new method for preoperative assessment of endothelial viability in donor corneal tissues for transplantation, and to correlate endothelial health as assessed by the surgical team to functional and structural long-term outcomes in the cohort of patients receiving them.
Trial Details
NCT Number NCT05847387
Lead Sponsor Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Conditions
(from sponsor)		 Corneal Transplant Failure, Corneal Endothelial Cell Loss
Related terms Corneal Endothelial Cell Loss
Enrollment 135 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov