Evaluating a new method for Implantable Collamer Lens implantation to treat high myopia
Prospective, Multicenter,Randomized Clinical Investigation of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation to Treat High Myopia: A Pilot Study
This study is testing a new way to implant a special lens for people with severe nearsightedness to see if it’s safer and works better than the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Wenzhou Medical University Academic / other |
| Locations | 5 sites (Guangzhou, Guangdong and 4 other locations) |
| Trial ID | NCT03059043 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with stable high myopia who meet specific ocular health criteria and have a best spectacle-corrected visual acuity of 20/40 or better.
Not a fit: Patients with preexisting ocular diseases, systemic conditions, or those who are pregnant or planning to become pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could lead to safer and more effective ICL implantation for patients with high myopia.
How similar studies have performed: While the standard method has been widely used, this viscoelastic-free approach is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong and 4 other locations
- Guangdong General Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Hunan Provincial People's Hospital — Changsha, Hunan, China (Not_yet_recruiting)
- The Eye Hispital of Wenzhou Medical University — Wenzhou, Zhejiang, China (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.