Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation
Prospective, Multicenter,Randomized Clinical Investigation of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation to Treat High Myopia: A Pilot Study
Wenzhou Medical University
60 participants
Nov 16, 2018
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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
- 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 Criteria4
- 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
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Interventions
Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation
This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT03059043