Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04616144 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from May 1, 2026 to May 1, 2027v7
  2. Study completion date: May 1, 2024 to May 1, 2026v6
  3. 2 versions Re-verified since Jul 26, 2022, no change to tracked fieldsv4-v5
  4. Enrollment target: 10 to 55
    • Primary endpoint revised
    • Study completion date: May 1, 2022 to May 1, 2024
    v3
  5. Secondary endpoint revisedv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The refractive combination of high hyperopia with high astigmatism is difficult to treat surgically. In addition, there are not many suitable options to offer such patients presenting with this condition. The method used at the EYE Hospital Pristina using fresh lenticule implantation by ReLex-SMILE is safe and effective method. Fresh Corneal Implantation is a safe treatment for hyperopia with high astigmatism comparing with refractive IOL implantation (loss of accommodation, endophthalmitis). Its primary objective is to increase visual acuity, accommodation process, patient satisfaction which makes patient to enjoy a happier life. We believe this study will be the future of refractive surgery for treating high hyperopia.
Trial Details
NCT Number NCT04616144
Lead Sponsor Eye Hospital Pristina Kosovo
Conditions
(from sponsor)		 Hyperopia, High Astigmatism
Related terms Hyperopia
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov