Clinical Trial

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

Not Yet Recruiting

Record status

This record was last updated August 8, 2025 (before its estimated November 30, 2025 completion). Its status may not reflect the trial's current state.

Summary

Implantable collamer lens (ICL) implantation is considered one of the most effective surgical treatments for high myopia. The procedure primarily involves adjusting the position of the ICL within the eye. However, precise calculation of the ICL optical power may cause the surgical light source to remain focused on the macular area during this process, potentially leading to iatrogenic light-induced damage. Theoretically, the combination of a 3D visualization surgical system and coaxial illumination technology can reduce the illumination intensity and decrease iatrogenic light damage. This study aims to compare the retinal physiological changes in patients undergoing ICL surgery through 3D visualization surgical system with coaxial illumination versus a traditional microscope with standard illumination.

Protocol Amendment History 2 amendments

This ClinicalTrials.gov record has been amended 2 times since 2025-05-04; most recent amendment 2025-08-07.

Trial Details

NCT Number	NCT06966622
Lead Sponsor	Fuzhou Eye Hospital Collaborators: Alcon Research
Conditions	High Myopia
Enrollment	40 participants
Start Date	2025-08-25
Primary Completion	2025-11-30 (estimated)
Study Completion	2026-05-31 (estimated)
Updated on ClinicalTrials.gov	2025-08-08