Epithelium-on Accelerated Corneal Cross-linking Versus Observation of Fellow Eyes of Young Patients With Unilateral Clinically Evident Keratoconus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Maximum keratometry value
研究概览
简要总结
Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease. The management of young patients, diagnosed with clinically evident KC in one eye and with no clinical signs of KC in the other eye, represents a real challenge for many ophthalmologists.
The aim of the current study is to investigate the effectiveness and safety of epithelium-on accelerated CXL to stabilize the eye with no clinical signs of KC, in young patients with unilateral clinically evident KC, compared with standard care and follow-up only.
详细描述
Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease associated with corneal thinning and protrusion with resultant irregular astigmatism and visual loss.
Although several studies showed that epithelium-off corneal cross-linking (epi-off CXL) is more effective in preventing KC progression compared with epithelium-on corneal cross-linking (epi-on CXL), the removal of corneal epithelium in epi-off CXL might be associated with a number of serious complications such as persistent epithelial defects and sight-threatening infectious keratitis. Additionally, recent systematic reviews and meta-analysis concluded that epi-on CXL is as effective as epi-off CXL in terms of visual and topographic stability of keratoconus, but has the advantage of being much safer avoiding the complications of epithelial removal.
The management of the better eye, of young patients with unilateral clinically evident KC, is controversial. Some ophthalmologists prefer to cross-link the better eye, while others prefer to conservatively follow it up, in order to avoid complications of epithelial removal in epi-off CXL.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 12 to 30 years presented with forme fruste (FFKC) or subclinical KC, based on the following criteria:
- •Normal slit lamp examination
- •Normal topography in FFKC and suspicious topography in subclinical KC with asymmetric bow-tie or inferior steeping (inferior-superior value less than 1.40 D in the anterior sagittal curvature map in pentacam)
- •Clinical and topographic features of KC in the other eye.
排除标准
- •Corrected distance visual acuity (CDVA) worse than 0.1 logMAR
- •Corneal thickness at the thinnest location less than 400 μm
- •Severe ocular allergy (active catarrhal keratoconjunctivitis)
- •Other corneal or ocular diseases
- •Systemic diseases such as diabetes mellitus and autoimmune diseases
结局指标
主要结局
Maximum keratometry value
时间窗: 24 months
The maximum keratometry is measured using pentacam. A higher value means a worse outcome.
Steep keratometry value
时间窗: 24 months
The steep keratometry is measured using pentacam. A higher value means a worse outcome.
次要结局
- Corrected distance visual acuity(24 months)
研究者
Mahmoud Abdel-Radi
Principal Investigator
Assiut University