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

Fuzhou Eye Hospital

Status: Not yet enrolling

Conditions: High Myopia

Treatments: Procedure: 3D visualization system with coaxial illumination; Procedure: microscope with standard illumination

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06966622

FZYKYY-KY-2025-002

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

3D visualization system

Experimental group

Treatment:

Procedure: 3D visualization system with coaxial illumination

Microscope

Active Comparator group

Treatment:

Procedure: microscope with standard illumination