Comparing Visual Outcomes After FemtoLasik and Implantable Collamer Lens in Treatment of Myopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Refractive Stability (%)
研究概览
简要总结
Compare the clinical outcomes of FemtoLASIK and ICL implantation in treating moderate myopia.
详细描述
The clinical outcomes of FemtoLASIK and ICL implantation focusing on refractive stability, contrast sensitivity and high order aberrations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group I - FemtoLASIK subgroup:
- •Age range: 21-40 years.
- •Stable myopia for at least one year (refractive change
- •Spherical equivalent between -4.00 D and -8.00 D.
- •Corneal thickness ≥ 500 μm, residual stromal bed > 300 μm and percentage of tissue altered < 39%.
- •No evidence of keratoconus or ectatic changes on corneal topography/tomography.
- •Mesopic pupil diameter ≤ 6.5 mm.
- •Absence of ocular surface disease or significant dry eye symptoms.
- •No history of prior ocular surgery or trauma.
- •Group II - ICL subgroup:
- •Age range: 21-40 years.
- •Stable myopia (with or without astigmatism) for ≥1 year.
- •Spherical equivalent between -4.00 D and -8.00 D.
- •Anterior chamber depth ≥ 2.8 mm from endothelium.
- •Endothelial cell density ≥ 2500 cells/mm².
- •White-to-white and sulcus-to-sulcus diameters suitable for ICL sizing.
- •Clear crystalline lens with no signs of early cataract.
- •No history of intraocular surgery, uveitis, or glaucoma.
排除标准
- •Patients with mild myopia (<-4D) or high myopia (>- 8D) or hyperopia.
- •Patients with media opacity.
- •Patients with associated ocular pathology.
- •Patients with corneal topography not fitting to either treatment modalities.
结局指标
主要结局
Refractive Stability (%)
时间窗: From enrollment up to 6 months postoperative
calculating the ratio between spherical equivalent postoperative to that of preoperative
Contrast Sensitivity (log CS)
时间窗: From enrollment up to 6 months postoperative
using specialized charts and measured in logarithmic contrast sensitivity (log CS) units
High Order Aberrations (μm)
时间窗: From enrollment up to 6 months postoperative
using the RMS value to quantify the total magnitude of wavefront deviations in the eye in micrometers
次要结局
未报告次要终点
研究者
Walid Osama Abdel Rahman Nour El Din
Cornea and Refractive Ophthalmology Consultant
Fayoum University