Effectiveness and Safety of Corneal Collagen Cross Linking After Induction of Stromal Emphysema in Keratoconus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Evaluating effectiveness of Cross-linking in the presence of air in corneal stroma
研究概览
简要总结
in this study we evaluated the effectiveness and safety of corneal collagen cross-linking in keratoconic eyes with thin cornea after induction of stromal emphysema prior to riboflavin instillation and UV-A corneal irradiation
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
- 17 Years 至 33 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Progressive KC proven by clinical examination, tomography, and pachymetry
- •Thinnest corneal location thickness between 390 to 450 microns
排除标准
- •Previous ocular Trauma or Surgery.
- •History of herpetic eye disease
- •Central corneal scarring
- •Cornea guttata
- •Ocular surface disease and dry eye disease
- •Vernal and atopic keratoconjunctivitis
- •Glaucoma, intraocular pressure less than 10 or more than 21 mmHg
- •Posterior segment abnormalities
- •Nystagmus or other conditions that interfere with patient's fixation
- •Diabetes mellitus
- •pregnancy
- •Collagen vascular disease, autoimmune disease and patients receiving immunosuppressive therapy
研究组 & 干预措施
Patients with progressive keratoconus
干预措施: Corneal collagen cross-linking with induction of corneal stromal emphysema (Procedure)
结局指标
主要结局
Evaluating effectiveness of Cross-linking in the presence of air in corneal stroma
时间窗: Corneal tomography will be performed preoperatively then 6, and 12 months after the procedure
Through serial corneal tomography
Assessment of the safety of this procedure on corneal endothelial cells
时间窗: Specular microscopy will be performed preoperatively, then 1, 3 and 6 months after the procedure
By evaluating corneal endothelium structural integrity, using serial specular microscopy imaging
Measuring demarcation line depth in microns from corneal epithelium
时间窗: one month after procedure
both reflectivity and depth (in microns) of demarcation line will be evaluated by using corneal OCT
次要结局
- To detect changes in the visual acuity (in decimal)(preoperatively then 1 week and 1, 3, 6, and 12 months after the procedure.)
研究者
Ahmed Rashad Ashor
Lecturer of Ophthalmology, Principal investigator
Cairo University