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

ConditionMyopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorWenzhou Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators