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Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation With ReLEX Smile Surgery

Study acronym: Relex-Smile
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv9
  2. Trial status changed: Enrolling by Invitation → Active, Not Recruiting
    • Final enrollment: 42 participants (planned 60)
    • Study completion moved earlier from Nov 8, 2027 to Sep 8, 2027
    v8
  3. Primary completion date: Jan 8, 2020 to Jan 8, 2018
    • Study completion date: Nov 8, 2025 to Nov 8, 2027
    • Start date: Jan 8, 2019 to Jan 8, 2017
    v7
  4. Study completion date: Dec 8, 2023 to Nov 8, 2025v6
  5. Study completion date: Jan 8, 2023 to Dec 8, 2023v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study description expanded, about 11 wordsv4
  2. Enrollment target: 30 to 60
    • Study completion date: Jan 8, 2022 to Jan 8, 2023
    • Study description expanded, about 97 words
    v3
  3. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
LASIK (laser-assisted in situ keratomileusis) is a type of refractive surgery for correction of myopia, hyperopia and astigmatism. Yet approximately 30% of operated patients have symptoms like glare, halos, dry eyes and especially residual hypermetrop refractive errors. Residual hypermetrop refractive errors are difficult to treat surgically, the current treatment is Refractive Lens Implantation - risks are similar to those of cataract surgery (endophthalmitis, loss of accommodation, etc.)
Trial Details
NCT Number NCT04793893
Lead Sponsor Eye Hospital Pristina Kosovo
Conditions
(from sponsor)		 Refractive Errors
Related terms Refractive Errors
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov