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Human Fresh Corneal Lenticule Implantation Criteria in Progressive Corneal Disease Using Relex-Smile

Study acronym: Relex-Smile
StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Feb 1, 2026 → Feb 1, 2027
See other at-risk trials from Eye Hospital Pristina Kosovo

Record History

  1. Primary completion pushed from Feb 1, 2026 to Feb 1, 2027v6
  2. Primary completion date: Feb 1, 2021 to Feb 1, 2026
    • Study completion date: Feb 1, 2025 to Feb 1, 2027
    v5
  3. Study completion date: Feb 1, 2024 to Feb 1, 2025v4
  4. Re-verified, no change to tracked fieldsv3
  5. Study completion date: Feb 1, 2022 to Feb 1, 2024v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Stroma is a fibrous, tough, transparent and the thickest layer of the corneae. The stroma is composed of organised collagen, which maintains transparency. Keratocytes are located between the lamella collagen fibers and secrete an extracellular matrix, which includes collagen, proteoglycan, crystalline proteins to maintain corneal transparency.
Trial Details
NCT Number NCT04848740
Lead Sponsor Eye Hospital Pristina Kosovo
Conditions
(from sponsor)		 Progressive Disease of Corneae
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov