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

NCT03059043 · tracked via the Priya Life Science China tracker

Sponsor

Wenzhou Medical University

Phase

Not applicable

Started

2018-11-16

Last updated

2026-08-18

Condition(s) studied

Myopia

Investigational drug(s) / intervention(s)

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

Trial sites (5)

Facility	City	Region	Status
Guangdong General Hospital	Guangzhou	Guangdong	Not Yet Recruiting
Hunan Provincial People's Hospital	Changsha	Hunan	Not Yet Recruiting
The Eye Hispital of Wenzhou Medical University	Wenzhou	Zhejiang	Recruiting
Peking Union Medical College Hospital	Beijing	China	Not Yet Recruiting
Shanghai Ninth People's Hospital	Shanghai	China	Not Yet Recruiting

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Official registry record

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.

View NCT03059043 on ClinicalTrials.gov ↗ ← All trials in China