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

ConditionHigh Myopia

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-40

SponsorFuzhou Eye Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Cataracts

Corneal diseases,

Glaucoma,

Nystagmus,

Trial design

Design model

Parallel

Treatments tested in this trial

3D visualization system with coaxial illumination
Procedure/Surgery
operation through 3D visualization system with coaxial illumination
microscope with standard illumination
Procedure/Surgery
operation through microscope with standard illumination

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: 3D visualization systemExperimental treatment 1 intervention

Group B: MicroscopeActive comparator 1 intervention