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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Wenzhou Medical University • ClinicalTrials.gov ID: NCT03059043

Registry updated: 2026-08-18
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Description

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.

Interventions

  • viscoelastic-free implantation system (Device)
    Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation
  • standard viscoelastic-assisted Implantation system (Device)
    This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation

Eligibility criteria

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

Conditions

Myopia

Locations

  • Guangdong General Hospital — Guangzhou, Guangdong, China
  • Hunan Provincial People's Hospital — Changsha, Hunan, China
  • The Eye Hispital of Wenzhou Medical University — Wenzhou, Zhejiang, China
  • Peking Union Medical College Hospital — Beijing, China
  • Shanghai Ninth People's Hospital — Shanghai, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record