Outcomes of Keraring Implantation in Patients With Keratoconus Guided by the Alfonso Morphological Surgical Nomogram
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Corrected distance visual acuity
研究概览
简要总结
Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease associated with corneal thinning and protrusion. The management of moderate progressive keratoconus involves halting its progression through corneal cross-linking as well as flattening of the ectatic steep cornea through the implantation of intrastromal corneal rings (ICR). Different nomograms were used to guide ophthalmic surgeons for the proper choice of ICR implantation to achieve the best results. The aim of the current study is to assess the visual, refractive and tomographic outcomes of Keraring implantation based on the Alfonso nomogram, in patients with keratoconus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18-35 years.
- •Patients diagnosed with progressive keratoconus.
- •Mean keratometry (Km) between 48-60 D.
- •Clear cornea
排除标准
- •Mild or advanced keratoconus
- •Corneal scarring.
- •Other corneal or ocular diseases.
- •Systemic diseases such as diabetes mellitus and autoimmune diseases.
研究组 & 干预措施
Keraring implantation based on Alfonso nomogram
Patients with moderate progressive keratoconus, underwent Keraring implantation based on Alfonso morphological surgical nomogram.
干预措施: Intrastromal corneal ring segment implantation (ICRS) (Procedure)
结局指标
主要结局
Corrected distance visual acuity
时间窗: 6 months
Corrected distance visual acuity is measured with Snellen's acuity chart and converted to logarithm of the minimum angle of resolution (logMAR) notation.
Spherical equivalent refraction
时间窗: 6 months
Spherical equivalent in diopters is measured with Topcon autorefractometer.
Maximum keratometry
时间窗: 6 months
The maximum keratometry in diopters is measured using pentacam.
次要结局
未报告次要终点
研究者
Mahmoud Abdel-Radi
Professor
Assiut University