🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT03059043
Recruiting Not applicable

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)

Trial sites (5)

FacilityCityRegionStatus
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

More Wenzhou Medical University trials in China

Other trials for the same condition

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