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临床试验/CTRI/2021/11/037724
CTRI/2021/11/037724尚未招募不适用

Autologous Simple Limbal Epithelial Transplantation in the management of Unilateral Total Limbal Stem Cell Deficiency due to severe chemical burn.

SNMedical College Agra1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年8月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
试验地点
1
主要终点
Ocular surface stability(completely epithealized and avascular corneal surface)

研究概览

简要总结

Limbal stem cells are located at corner scleral limbus in the palisade of Vogt.They represent the proliferative reserve.So if the limbus is intact ,all epithelial defects will heal promptly.Damage to limbal stem cells due to injury or disease can lead to limbal stem cell deficiency.One of the important causes of LSCD is chemical injury.Chemical injury accounts for 11.5-20% of ocular Trauma.Depending upon the severity of damage caused to limbus and conjunctiva, the extent of cifichemical burns may be graded by Dua’s classification.According to literature ,In severe  unilateral chemical burn ,where limbal stem cells are damaged 360 degree, SLET has helped to restore the ocular surface integrity. of c

Keeping this in view ,at our centre we want to offer this service of  SLET to our patients of severe unilateral chemical injury.

So this study aims to study the surgical outcome of Autologous Simple Limbal Epithelial Transplantation in  the management of unilateral limbal stem cell deficiency due to severe chemical burn in terms of ocular surface stability(completely epithelialized,avascular corneal surface),Post operative uncorrected visual acuity .

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
10.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Documented history of chemical burn Unilateral cases of chemical Burn.

排除标准

  • Unknown cases of LSCD B/L cases of LSCD Recurrent Pterygium and ocular surface tumor Active infection Disorganised Anterior Segment PL absent.

结局指标

主要结局

Ocular surface stability(completely epithealized and avascular corneal surface)

时间窗: F/U on day1,day 7 ,day 15 post op day respectively and then monthly till the completion of study

Post operative uncorrected visual acuity

时间窗: F/U on day1,day 7 ,day 15 post op day respectively and then monthly till the completion of study

次要结局

  • intra operative and post operative complications(F/U on day1,day 7 ,day 15 post op day respectively and then monthly till the completion of study)

研究者

发起方
SNMedical College Agra
申办方类型
Government medical college

研究点 (1)

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