Comparison of Ngenuity and Traditional Microscopy in Assessing Retinal Function Recovery Post-ICL Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Primary Endpoint
- b-wave amplitude
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Microscope
Intervention: microscope with standard illumination (Procedure)
3D visualization system
Intervention: 3D visualization system with coaxial illumination (Procedure)
Outcomes
Primary Outcomes
b-wave amplitude
Time Frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
Secondary Outcomes
- a-wave amplitude(1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op)
- macular vessel density(1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op)
- Uncorrected visual acuity(1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op)
- Best-corrected visual acuity(1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op)