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临床试验/NCT04966806
NCT04966806Unknown不适用

Contribution of Spherical Aberration and Coma to The Total Ocular High Order Aberration Before and After Femtosecond Laser-Assisted in Situ Keratomileusis Using An Aspheric Ablation Profile

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2021年7月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
17
试验地点
1
主要终点
Change in percentage of contribution of coma and spherical aberration from total ocular HOA before and after FS-LASIK.

研究概览

简要总结

Laser-assisted in situ keratomileusis (LASIK) is the most frequently performed refractive surgery procedure for the correction of myopia, hyperopia, and astigmatism.

There is a continuous upgrade and development in LVC surgeries correlated with the evolution of new machines and enhancement of the ablation profiles. One of the main undesirable effects of corneal refractive surgeries using conventional ablation profiles is the increase in HOAs which is associated with haloes, glare, ghost images, starburst patterns and monocular diplopia, especially in low lighting conditions and during night driving.

Over the years many ablation profiles have been developed such as wavefront-guided, wavefront optimized, topography guided, Q- Value based and aspheric ablation profiles. These profiles aim to abolish LOAs and to prevent induction or increase of pre-existing HOAs aiming to improve the quality of vision experienced post-operative.

In spite of the vast body of research in this area, there remains a gap in the literature investigating higher-order aberrations' components in-depth. Therefore, this study aims to investigate the contribution of spherical aberration and coma to the total higher order aberration before and after femtosecond assisted laser in situ keratomileusis using an aspheric ablation profile.

This current study is a Descriptive analytical study that was conducted on 34 eyes of 17 patients who underwent corneal refractive surgery.

The results were analyzed to compare the effect of FS-LASIK surgery on corneal coma and SA, and the contribution of each of them on total ocular HOAs preoperative and post-operative.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: between 18 years and 45 years
  • Myopes from -1.50 D to -8.00 D
  • Astigmatism less than -4.00 D
  • Normal Corneal Tomography with a Belin Ambrosio big D value of less than 1.6

排除标准

  • Unstable refraction for 1 year
  • Corneal thickness less than 500 microns
  • Expected Post Lasik Residual Stromal bed less than 300 microns
  • All patients with post operative complications as epithelial overgrowth or decentered ablation.

结局指标

主要结局

Change in percentage of contribution of coma and spherical aberration from total ocular HOA before and after FS-LASIK.

时间窗: 6 months

Measuring unit for coma and spherical aberrations and total ocular HOA is equivalent Diopters. The contribution of coma and spherical aberrations to total ocular HOA will be measured as a percentage.

次要结局

未报告次要终点

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paula Sameh Youssef

Resident.

Kasr El Aini Hospital

研究点 (1)

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