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Search / Trial NCT06966622

Comparison of Retinal Damage in ICL Implantation Using 3D Visualization System vs. Microscope

Launched by FUZHOU EYE HOSPITAL · May 4, 2025

Trial Information

Current as of July 25, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of a new 3D visualization system compared to a traditional microscope during a specific eye surgery called ICL (Implantable Collamer Lens) surgery, which is used to treat high myopia or severe nearsightedness. The goal is to see if using 3D technology can improve the health of the retina, the light-sensitive tissue at the back of the eye, after surgery. The study will involve 40 participants aged between 18 and 40 years who have stable high myopia and meet other specific eye health criteria.

If you are eligible to participate, you will undergo either the surgery using the regular microscope or the new 3D system, but all surgeries will be performed by the same experienced surgeon under the same conditions. The study will track your recovery and measure changes in your vision and the health of your retina at various points after the surgery, up to 30 days later. It's important to know that this trial is not yet recruiting participants, but it aims to explore potential advantages of the 3D approach in making the surgery safer and more effective.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Clinical diagnosis of high myopic
  • Aged 18-40 years
  • Desire to improve their refractive status via ICL surgery
  • Relatively stable refractive error (change ≤ 0.50 D per year for two consecutive years)
  • Central anterior chamber depth ≥ 2.8 mm
  • Open angles
  • Corneal endothelial cell density ≥ 2000 cells/mm2.
  • Exclusion Criteria:
  • Cataracts
  • Corneal diseases,
  • Glaucoma,
  • Nystagmus,
  • Strabismus,
  • Lens subluxation,
  • Severe vitreoretinal diseases,
  • Other ocular diseases
  • A history of ocular trauma
  • A history of ocular surgery

About Fuzhou Eye Hospital

Fuzhou Eye Hospital is a leading medical institution specializing in comprehensive eye care and innovative ophthalmic research. Committed to advancing the field of ophthalmology, the hospital engages in clinical trials aimed at developing and evaluating cutting-edge treatments and technologies for various eye conditions. With a team of experienced healthcare professionals and researchers, Fuzhou Eye Hospital prioritizes patient safety and ethical standards while striving to enhance visual health outcomes. By fostering collaboration and leveraging state-of-the-art facilities, the hospital aims to contribute significantly to the global body of knowledge in eye care and improve the quality of life for patients worldwide.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported