High Myopia
Conditions
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.
Interventions
PROCEDURE3D visualization system with coaxial illumination
operation through 3D visualization system with coaxial illumination
PROCEDUREmicroscope with standard illumination
operation through microscope with standard illumination
Sponsors
Alcon Research
Fuzhou Eye Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| b-wave amplitude | 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Other
| Measure | Time frame |
|---|---|
| Intraoperative illumination intensity | surgery beginning |
| Surgical time | Starting with the making of the surgical incision and ending with incision closure |
Outcome results
None listed