Evaluating a new method for Implantable Collamer Lens implantation to treat high myopia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses the safety and efficacy of a viscoelastic-free method for Implantable Collamer Lens (ICL) implantation in patients with high myopia. Participants will have one eye treated using the new method and the other eye using the standard viscoelastic-assisted method, allowing for a direct comparison of outcomes. Post-operative data will be collected at multiple follow-up intervals to evaluate the clinical effectiveness and safety of both techniques. The goal is to determine if the new method can reduce complications associated with viscoelastic agents during surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• The Eye Hispital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting
• Guangdong General Hospital
  Guangzhou, Guangdong, China Not yet recruiting
• Hunan Provincial People's Hospital
  Changsha, Hunan, China Not yet recruiting
• Peking Union Medical College Hospital
  Beijing, China Not yet recruiting
• Shanghai Ninth People's Hospital
  Shanghai, China Not yet recruiting

Study contacts

• Principal investigator: AYong Yu, MD. PhD. — Wenzhou Medical University
• Study coordinator: AYong Yu, MD. PhD.
• Email: yaybetter@hotmail.com
• Phone: +86-0577-88068880

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.