Actively Recruiting
Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation
Led by Wenzhou Medical University · Updated on 2024-07-23
60
Participants Needed
5
Research Sites
396 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Myopic refractive error from -0.5D to -18.0D
- Anterior chamber depth at least 2.8 mm to endothelium
- Endothelial cell density (ECD) more than 2000 cells/mm2
- Pupil diameter smaller than 7.0 mm under mesopic condition
- Discontinued hard contact lens use for 3 weeks and soft contact lens use for 1 week
You will not qualify if you...
- Preexisting ocular diseases or conditions other than myopia, or evidence of progressive or acute ocular disease
- Evidence of connective tissue disease or other systemic diseases that may affect study results
- Narrow angle of anterior chamber
- Pregnant, lactating, or planning to become pregnant during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Guangdong General Hospital
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
2
Hunan Provincial People's Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
3
The Eye Hispital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
4
Peking Union Medical College Hospital
Beijing, China, 100000
Not Yet Recruiting
5
Shanghai Ninth People's Hospital
Shanghai, China, 200000
Not Yet Recruiting
Research Team
A
AYong Yu, MD. PhD.
CONTACT
A
Anpeng Pan, MD.OD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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