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临床试验/NCT01610973
NCT01610973已完成不适用

Comparison of Manual and Automated Techniques in Achieving Posterior Lamellar Transplantation of the Cornea

University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Measurement of visual acuity

研究概览

简要总结

The cornea is a transparent membrane, half a millimeter thick, embedded as a window in front of the eye.

When the eye becomes opaque, the eye is not seeing and the only way to restore the visual acuity is to replace the cornea by performing a graft (4000 surgeries per year in France). In half the cases the opacification of the cornea is secondary to dysfunction of the endothelium, cell layer of 15 μm thickness, covering its posterior surface, in charge of regulating the moisture of the corneal thickness and therefore its transparency.

While the total corneal transplantation has long been the only intervention for these diseases, it is now possible, from 4-5 years, to replace only the very thin: it is called endothelial transplant or graft lamellar later. This intervention is now experiencing significant success as it reduces very significantly the incidence of complications found after transplantation of total cornea and the visual recovery period. This type of transplant is still difficult to achieve and the best technique is not yet established.

Indeed, posterior lamellar transplantation of the cornea may be done manually or using an automated device. Manual techniques allow the preparation of grafts extremely thin but are difficult to achieve while the automatic techniques, easier, prepare thicker grafts that may be less efficient in visual recovery.

The aim of this project is to conduct a prospective study in order to compare these two techniques in terms of postoperative visual recovery and the vitality of the graft during the first year. To date, there is no such study.

The department of Ophthalmology in the University Hospital of Rouen is one of the most famous French teams in the field of cornea transplants and receives many patients from different French regions. The recruitment of 40 patients needed to study should be done without great difficulty over a period of 18 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • men and woman
  • 18 years old or more
  • Patient having been informed about the study and having signed a non-opposition to the participation

排除标准

  • Patient presenting an associated eye pathology previously known and able to limit the visual recovery (age-related macular degeneration, diabetic retinopathy, ...)
  • Pregnant women, parturient or breast feeding
  • refusal to participate in the study

结局指标

主要结局

Measurement of visual acuity

时间窗: 1 year

次要结局

  • Occular hypertension(Day 7, Day 15, Month 1, Month 2, Month 6, 1 year)
  • Partial or complete graft detachment(Day 7, Day 15, Month 1, Month 2, Month 6, 1 year)
  • Defeat of the graft(Day 7, Day 15, Month 1, Month 2, Month 6, 1 year)
  • Necessity of air injection(Day 7, Day 15, Month 1, Month 2, Month 6, 1 year)
  • Measurement of visual acuity(Month 1, Month 2, Month 6)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (2)

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