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Tests treatment safety and results for Myopia
Official title Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation
ClinicalTrials.gov ID: NCT03059043
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Changsha, Hunan, China
- Wenzhou, Zhejiang, China
- Beijing, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Changsha, Hunan, China; Wenzhou, Zhejiang, China; Beijing, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.