Comparison of Retinal Damage in ICL Implantation Using 3D Visualization System vs. Microscope
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D visualization system with coaxial illumination, microscope with standard illumination.
- Who it may be relevant to
- Registry conditions: High Myopia. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Ngenuity and Traditional Microscopy in Assessing Retinal Function Recovery Post-ICL Surgery
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.
Interventions
- 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
Primary outcome measures
- b-wave amplitude [Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op]
Secondary outcome measures (4)
- a-wave amplitude [Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op]
- macular vessel density [Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op]
- Uncorrected visual acuity [Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op]
- Best-corrected visual acuity [Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06966622 · FZYKYY-KY-2025-002