Visual and Topographic Outcomes of Corneal Allogenic Ring Segments in Keratoconus
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Improvement in UCVA by range of ≥ 2 lines
研究概览
简要总结
My Postgraduate Thesis is on Visual and Topographic Outcomes of corneal allogenic intrastromal ring segments in Keratoconus.
Keratoconus is a slowly progressive, non inflammatory ectatic corneal disease characterized by changes in corneal collagen structure and organization. Prevalence of keratoconus (KC) is estimated at 2300/100,000 in Central India (0.0003–2.3%) highlighting the fact that keratoconus is much more prevalent than what is assumed.
Corneal collagen crossâ€linking is effective in stabilizing the progression of the disease but does not have a major impact on the improvement of visual acuity. Common methods of vision correction for keratoconus range from spectacles and rigid gasâ€permeable contact lenses to other specialized lenses such as piggyback, Roseâ€K, or Boston scleral lenses.
Intrastromal corneal ring segments (ICRS) are small curvilinear segments which are made of PMMA, synthetic material that are placed deep in the corneal stroma to alter the corneal curvature and regularization of the corneal surface. However, being made of synthetic material, upto 30% rate of complications ranging from innocuous to sight threatening are reported.
Corneal Allogenic Intrastromal Ring Segments is a new technique that utilizes a principle similar to synthetic segments but with the use of allogenic segments created from donor corneal buttons. This technique aims at decreasing the complications associated with the use of synthetic material within the patient’s corneal stroma and improving the visual outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Grade 1 to 4 Keratoconus patients (Amsler Krumeich grading) showing progression with sufficient minimum pachymetry.
排除标准
- •Autoimmune and immunodeficiency syndromes Previous viral keratitis Thin cornea less than 350 micrometers.
结局指标
主要结局
Improvement in UCVA by range of ≥ 2 lines
时间窗: Follow up at 1 week, 1 month, 3 months, 6 months and 1 year.
Improvement in BCVA by ≥ 1 line
时间窗: Follow up at 1 week, 1 month, 3 months, 6 months and 1 year.
Decrease in spherical and astigmatic error
时间窗: Follow up at 1 week, 1 month, 3 months, 6 months and 1 year.
Decrease in keratometry
时间窗: Follow up at 1 week, 1 month, 3 months, 6 months and 1 year.
次要结局
- Incidence of inflammatory keratitis(Over correction or Under Correction of Refractive error)
研究者
Dr Shivohn Annalie da Silva
Sankara Eye Hospital, Coimbatore
