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临床试验/NCT01893671
NCT01893671已完成不适用

Observational Study of Corneal Power, Astigmatism, and Aberration Changes After LASIK

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
OCT measurement of corneal power and astigmatism vs Placido-ring

研究概览

简要总结

The primary goal of the study is to determine if Optical Coherence Tomography (OCT) measurement of corneal power and astigmatism is more accurate than conventional Placido-ring corneal topography. A second goal is to evaluate OCT-based epithelial thickness mapping. The postoperative epithelial thickness variation will be used to calculate refractive effects and calibrate the smoothing parameter in the mathematical model relating corneal mean curvature and epithelial thickness. A third goal is to assess the repeatability of OCT measurements. A fourth goal is to develop a method of estimating the focusing power, astigmatism, and HOA of the crystalline lens based on measurements of the lens' anterior and posterior capsular topographies and positions with the ultrahigh-speed MIT OCT prototype.

详细描述

A prospective observational study on refraction and HOA changes after LASIK will be conducted at OHSU and Baylor. We will enroll 50 subjects undergoing routine LASIK for the correction of myopia or hyperopia. The Optovue anterior segment OCT prototype will be used to measure corneal power, astigmatism, HOA, and epithelial thickness map. The ultrahigh-speed MIT OCT prototypes will also be used when they become available. A comprehensive eye examination will be performed preoperatively. OCT scan, manifest refraction, visual acuity, Placido-ring corneal topography, slit scanning/Scheimpflug camera, and wavefront measurements will be acquired preoperatively and 3-6 months after the surgery. The LASIK-induced refraction and wavefront HOA changes will be used as the reference standard to evaluate the accuracy of OCT-measured corneal power, astigmatism, and HOA changes. The primary goal of the study is to determine if OCT measurement of corneal power and astigmatism is more accurate than conventional Placido-ring corneal topography. A second goal is to evaluate OCT-based epithelial thickness mapping. The postoperative epithelial thickness variation will be used to calculate refractive effects and calibrate the smoothing parameter in the mathematical model relating corneal mean curvature and epithelial thickness. A third goal is to assess the repeatability of OCT measurements. A fourth goal is to develop a method of estimating the focusing power, astigmatism, and HOA of the crystalline lens based on measurements of the lens' anterior and posterior capsular topographies and positions with the ultrahigh-speed MIT OCT prototype. The reference standard for lens focusing power and astigmatism will be based on a Gaussian optics model that takes as inputs manifest refraction, crystalline lens position, axial eye length, and OCT corneal power and astigmatism measurements. The reference standard for lens HOA will be the difference between wavefront HOA and corneal HOA. For each eye, the best-fit effective index of the lens will be found so that OCT measurements will match the reference data. Although the lens index is likely to be higher centrally than peripherally, this secondary perturbation will be accounted for by a posterior shift of the posterior lens capsule in OCT images, due to the fact that apparent distances in OCT images is a product of physical distance and optical group index. Thus HOA due to index variation in the lens would translate to unevenness in the posterior capsule surface that could be measured with OCT.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Patients who qualify for primary LASIK for either myopia or hyperopia, with or without astigmatism.

排除标准

  • Inability to give informed consent.
  • Inability to maintain stable fixation for OCT imaging.
  • Inability to commit to required visits to complete the study.
  • Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery

结局指标

主要结局

OCT measurement of corneal power and astigmatism vs Placido-ring

时间窗: 5 year

primary goal of the study is to determine if OCT measurement of corneal power and astigmatism is more accurate than conventional Placido-ring corneal topography

次要结局

  • The Development of a method of estimating the focusing power, astigmatism, and HOA of the crystalline lens(5 year)
  • An evaluation of OCT-based epithelial thickness mapping(5 year)
  • OCT measurements repeatability(5 year)

研究者

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

David Huang

David Huang, MD, PhD, Professor of Ophthalmology, Oregon Health & Science University

Oregon Health and Science University

研究点 (1)

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