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临床试验/NCT05114928
NCT05114928已完成不适用

Correlation Between Changes in Corneal Asphericity and Progression of Keratoconus in Children

Benha University1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2021年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
1
主要终点
Changes in corneal asphericity (Q-value) in all subjects.

研究概览

简要总结

Keratoconus is a progressive corneal disease characterized by asymmetric corneal thinning and structural changes in corneal collagen which leads to decrease in visual acuity due to myopic shift, irregular astigmatism or corneal scarring. Early detection of the disease in children aids in halting the progression and improve their quality of life. There is no consensus regarding the progression criteria of the disease, we aimed to assess the changes in corneal asphericity in children after corneal collagen crosslinking and investigate any possible correlation with progression criteria widely used.

详细描述

The Keratoconus progression is defined as increasing by 1.0 diopter (D) or more in the maximum keratometry (Kmax), progressive deterioration in Minimal Corneal Thickness is also associated with KC progression, other methods have been investigated to confirm KC progression such as changes in manifest refraction, unaided visual acuity (UAVA), BCVA, posterior keratometric data and higher order aberrations (HOA) which are altered in KC and can aid to confirm disease progression. Q-value (a coefficient of corneal asphericity) reflects the shape of the cornea, its refractive power, and spherical aberration. The mean Q-value in normal cornea is -0.26 ± 0.18, the severity of KC and the Q-value are inversely related.

Mean Q-value in KC at 8mm zone is -0.84 and -1.10 for anterior and posterior corneal surfaces, respectively. Until now, no precise criteria of KC progression especially in cases had undergone previous trans-epithelial corneal collagen cross-linking (TE-CXL) to halt the progression of the disease. In the present study we aimed to analyze the correlation between the changes in Q-value and progression of the KC in children had undergone bilateral TE-CXL.

研究设计

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

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children that were diagnosed as bilateral progressive KC (stage I-III, according to amsler classification, Kmax change >1D between 2 scanning with at least 2 months apart), and their age were less than 16 years old at time of TE-CXL, topographic parameters were Kmax 47-60D and MCT more than 400μm.

排除标准

  • Eyes with central corneal scarring, amblyopic eyes, and other corneal pathologies that may alter Pentacam scanning.

结局指标

主要结局

Changes in corneal asphericity (Q-value) in all subjects.

时间窗: Baseline and annually after TE-CXL till 5 years of follow-up

Evaluate the changes in Q-value after Trans-epithelial corneal collagen cross-linking (TE-CXL) using pentacam.

次要结局

  • Correlation between Q-value changes and disease progression in both groups.(Baseline and annually after TE-CXL till 5 years of follow-up)
  • The Q-value as a predictive value in keratoconus progression.(Baseline and annually after TE-CXL till 5 years of follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Abdelshafy

Lecturer of Ophthalmology

Benha University

研究点 (1)

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