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

NCT03059043 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-23

No results posted yet for this 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.

Conditions

  • Myopia

Interventions

DEVICE

viscoelastic-free implantation system

Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation

DEVICE

standard viscoelastic-assisted Implantation system

This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation

Sponsors & Collaborators

  • Wenzhou Medical University

    lead OTHER

Principal Investigators

  • AYong Yu, MD. PhD. · Wenzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-16
Primary Completion
2026-06-22
Completion
2026-06-22

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03059043 on ClinicalTrials.gov