viscoelastic-free implantation systemstandard viscoelastic-assisted Implantation system
viscoelastic-free implantation system: Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation
standard viscoelastic-assisted Implantation system: This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation
Study summary
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
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Early Post-operative Intraocular Pressure — 2 hours after surgery Intraocular Pressure measured by non-contact tonometers
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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