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NCT Number: NCT01893671

Corneal Power, Astigmatism, and Aberration Changes After LASIK

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. OCT measurement of corneal power and astigmatism vs Placido-ring

    Time frame: 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

Secondary outcomes

  1. An evaluation of OCT-based epithelial thickness mapping

    Time frame: 5 year

    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.

  2. OCT measurements repeatability

    Time frame: 5 year

    An assessment of the repeatability of OCT measurements

  3. The Development of a method of estimating the focusing power, astigmatism, and HOA of the crystalline lens

    Time frame: 5 year

    The Development of 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jul 9, 2013
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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