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临床试验/NCT05717673
NCT05717673招募中不适用

Effect of Epi-Off Technique in Corneal Collagen Cross Linking On Endothelial Count by Using Specular Microscopy in Keratoconus Patients

Heba Allah Nashaat Mohamed1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Determine safety of CXL on corneal endothelial count by using specular microscopy in patients with keratoconus

研究概览

简要总结

Determine safety of EPi-off CXL on corneal endothelium by using specular specular microscopy to assess endothelial count.

详细描述

Specular microscopy is a noninvasive photographic technique that analyze the corneal endothelium. Using computer-assisted morphometry, modern specular microscopes analyze the size, shape and population of the endothelial cells. The instrument projects light onto the cornea and captures the image that is reflected from the optical interface between the corneal endothelium and the aqueous humor. The reflected image is analyzed by the instrument and displayed as a specular photomicrograph

Corneal collagen cross-linking (CXL) is a therapeutic procedure aiming at increasing the corneal stiffness in the keratoconus eyes by induction of cross-links within the extracellular matrix. It is achieved by ultraviolet-A (370 nm) irradiation of the cornea after saturation with the photosensitizer riboflavin. In the conventional CXL protocol, a minimum (manual) de-epithelialized corneal thickness of 400 μm is recommended to avoid potential irradiation damage to the corneal endothelium. In advanced keratoconus, however, stromal thickness is often lower than 400 μm, which limits the application of CXL in that category. Efforts have been undertaken to modify the conventional CXL procedure to be applicable in thin corneas. The current review discusses different techniques employed to achieve this end and their results. The overall safety and efficacy of the modified CXL protocols are good, as most of them managed to halt the progression of keratectasia without postoperative complications. However, the evidence of safety and efficacy in the use of modified CXL protocols is still limited to few studies with few patients involved. Controlled studies with long-term follow-up are required to confirm the safety and efficacy of it.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
10 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with corneal diseases that treated by collagen cross linking such as keratokonus and post lasic ectesia with corneal thickness above 400um at its thinnest location.

排除标准

  • Prior herpetic infection
  • Autoimmune disorders
  • corneal thickness below 400um at its thinnest location
  • Corneal opacity

结局指标

主要结局

Determine safety of CXL on corneal endothelial count by using specular microscopy in patients with keratoconus

时间窗: 6 months

by using specular microscopy to assess endothelial count to prevent corneal damages

次要结局

未报告次要终点

研究者

发起方
Heba Allah Nashaat Mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Heba Allah Nashaat Mohamed

Determine safety of CXL on corneal endothelial count by using specular microscopy in patients with keratoconus

Assiut University

研究点 (1)

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