Use of Gamma-Irradiated, Pre-cut Corneal Lenticules for Tectonic Keratoplasty in Patients with perforated corneal disease – A pilot study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Anatomical success - the restoration of tectonic integrity of globe
研究概览
简要总结
Summary Corneal blindness in India is one of the leading cause of bilateral blindness. 1.5-2 million people develop corneal ulcer annually and large proportion of these ulcers progress to perforation, resulting in severe ocular morbidities and even loss of globe. Such cases require an emergency surgery called therapeutic penetrating keratoplasty (TPK). Regrettably, there is a drastic mismatch between supply and demand of donor corneas worldwide, with only 1 cornea available for every 70 needed.
Primary objective of this study is to determine the feasibility of using gamma-irradiated corneal tissue for emergency keratoplasty in patients with corneal perforation. Main advantage of these tissues are, they can be stored at room temperature for up to two years and can be used by any ophthalmologist across the country reducing the dependency on eye banks. It has been successfully used for lamellar keratoplasty in western countries, but this will be the first prospective study for emergency TPK.
Expected Outcome
The ability to use long-term preserved cornealtissue/GICL might represent a means of relieving the burden of cornealblindness particularly in the developing world
And it offers an expansion of supply of donorcorneal tissue because of its advantages like
Ready availability
Long term storage capability at room temperature
Ease of use
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 19.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Perforated corneal ulcer of size – more than 6 mm but with at least 2 mm clear margin from limbus.
排除标准
- •Patients with potential good visual outcome with normal corneal transplants – Ulcer size less than 6mm Mono-ocular patient with other eye vision less than 6/60 Co-existing endophthalmitis or retinal detachment requiring retinal procedures.
结局指标
主要结局
Anatomical success - the restoration of tectonic integrity of globe
时间窗: 1 month and 6 months
Therapeutic success - defined as complete eradication of primary infection after keratoplasty with appropriate adjunctive medical therapy
时间窗: 1 month and 6 months
次要结局
- 1.Functional success - preservation of visual function with post op BCVA ranging from perception of light (PL), accurate projection of rays (PR) to 20/40(Complications)