跳至主要内容
临床试验/CTRI/2020/03/024283
CTRI/2020/03/024283尚未招募不适用

Evaluation of Quality of Vision after Deep Anteror Lamellar Keratoplasty

Department of Ophthalmology1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2020年3月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
35
试验地点
1
主要终点
Best Spectacle Corrected Visual Acuity (BSCVA)

研究概览

简要总结

Penetrating Keratoplasty (PKP) has been the treatment of choice for corneal diseases for the past 100 years. However during the last decade, because of advancement in surgical techniques, Deep Anterior Lamellar Keratoplasty (DALK), in which a maximal depth of corneal stroma is removed has gained popularity as an alternative to PK for the treatment of corneal diseases that do not affect the corneal endothelium and descemet membrane such as keratoconus, corneal stromal dystrophies and corneal stromal opacities. The main advantage of DALK is that it allows preservation of patient’s own endothelium, reducing the risk of immunological reactions, endothelial graft rejection and graft failure.

Multiple factors can limit post-DALK visual performance, including lower and higher order aberrations and light scatter caused by the surgical interface.However the relative contributions of these factors in visual performance after DALK are poorly understood.

The purpose of this study will be to evaluate the quality of vision after DALK in Indian eyes.These postoperative factors include those obtained by AS-OCT and corneal tomography, and anterior/posterior corneal HOAs.

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
7.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Age > 7 years
  • Corneal stromal diseases with normal endothelium
  • Willing to follow up for atleast 4 months post surgery.

排除标准

  • Gross posterior segment pathology
  • Ocular comorbidity like amblyopia and strabismus
  • Pregnant and lactating females.

结局指标

主要结局

Best Spectacle Corrected Visual Acuity (BSCVA)

时间窗: 4 months post surgery

次要结局

  • FACT contrast sensitivity(4 months post surgery)
  • Lenticule and residual host thickness(4 months post surgery)
  • Densitometry and Higher Order Aberrations from anterior and posterior corneal surface(4 months post surgery)

研究者

申办方类型
Government medical college

研究点 (1)

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