NCT06966622

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

Comparison of Ngenuity and Traditional Microscopy in Assessing Retinal Function Recovery Post-ICL Surgery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fuzhou Eye Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High Myopia

Interventions

Type	Name	Description
PROCEDURE	3D visualization system with coaxial illumination	operation through 3D visualization system with coaxial illumination
PROCEDURE	microscope with standard illumination	operation through microscope with standard illumination

Timeline

• Start date: 2025-08-25
• Primary completion: 2025-11-30
• Completion: 2026-05-31
• First posted: 2025-05-13
• Last updated: 2025-08-08