NCT03059043 Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation
| NCT ID | NCT03059043 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wenzhou Medical University |
| Condition | Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2018-11-16 |
| Primary Completion | 2026-06-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2018-11-16 with a primary completion date of 2026-06-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
AYong Yu, MD. PhD.
PRINCIPAL INVESTIGATOR
Wenzhou Medical University
Frequently Asked Questions
Who can join the NCT03059043 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03059043 currently recruiting?
Yes, NCT03059043 is actively recruiting participants. Contact the research team at yaybetter@hotmail.com for enrollment information.
Where is the NCT03059043 trial being conducted?
This trial is being conducted at Guangzhou, China, Changsha, China, Wenzhou, China, Beijing, China and 1 additional location.
Who is sponsoring the NCT03059043 clinical trial?
NCT03059043 is sponsored by Wenzhou Medical University. The principal investigator is AYong Yu, MD. PhD. at Wenzhou Medical University. The trial plans to enroll 60 participants.