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

N/ANot Yet RecruitingNCT06966622

Fuzhou Eye Hospital40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

High Myopia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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