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Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation

RecruitingNAAges 18 Years - 45 YearsAllWenzhou Medical University
NCT03059043 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study evaluates the safety and efficacy of a viscoelastic-free method for Implantable Collamer Lens(ICL) implantation to treat high myopia. The subjects undergo randomization of ICL implantation using the viscoelastic-free method on one eye and undergoing standard method on the other one. The post-operative data are collected for analysis.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Documented stable refraction for at least 1 year(within 0.5D) * Best spectacle-corrected visual acuity (BCVA) of 20/40 or better * Clear central cornea * -0.5D to -18.0D of myopic refractive error * Normal anterior chamber depth at least 2.8 mm to endothelium * Endothelial cell density (ECD) more than 2000 cell/mm2 * Pupil diameter smaller than 7.0 mm under mesopic condition * Discontinued 3 weeks for hard contact lens and 1 week for soft contact lens wear Exclusion Criteria: * Preexisting ocular diseases or conditions other than myopia, evidence of progressive or acute ocular disease * Evidence of connective tissue disease or other systemic diseases that may confound the results of the study; * Narrow angle of anterior chamber * Pregnant, lactating, or planning to become pregnant during the course of the trial
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What it tests

  • viscoelastic-free implantation system
  • standard viscoelastic-assisted Implantation system
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Where

5 sites
Guangdong General Hospital
Guangzhou, China
Hunan Provincial People's Hospital
Changsha, China
The Eye Hispital of Wenzhou Medical University
Wenzhou, China
Peking Union Medical College Hospital
Beijing, China
Shanghai Ninth People's Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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