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NCT Number: NCT05856786

To Study the Effects of Refractive Surgery on OCT Measurements in the Eye

Corrective eye surgeries, such as Lasik, are widely used to correct focusing problems such as myopia, or nearsightedness. Often these patients develop other conditions like myopic maculopathy or glaucoma which require monitoring with optical coherence tomography (OCT). Since OCT is a light-based test and changes the refractive status of the eye (in the cornea or the lens), it can potentially affect the results of the OCT measurements but has not been sufficiently studied. This pilot study aims at studying the potential change in OCT parameters in the eye after undergoing such surgery.

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Key information

Conditions

Optical Coherence Tomography Eye Diseases Myopia Refractive Errors

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Refractive surgeries are widely used in patients with ametropia. Refractive surgery is most commonly performed in patients with myopia. These patients often have a predilection for developing other conditions in the posterior segment of the eye, like myopic maculopathy or glaucoma which require monitoring with optical coherence tomography (OCT). Since OCT is a light-based test and changes in the refractive status of the eye (in the cornea or the lens) can potentially affect the results of the OCT measurements. Literature review reveals that the effect of significant changes in refractive power of the eye on the parameters of optical coherence tomography (OCT) has not been sufficiently studied. Some authors simulated the effect of refractive surgery using a contact lens but had diverging results. This prospective pilot study aims at studying the potential change in OCT parameters in the eye after undergoing refractive surgery.

Who can participate

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

Inclusion criteria

  • Patients undergoing refractive surgery
  • For patients undergoing bilateral eye surgery, the one with higher degree of ametropia will be included.

Exclusion criteria

  • Astigmatism more than 3 Diopters
  • Visual acuity worse than 20/25
  • Patients with unstable visual fixation
  • Severe Dry Eye

Treatment and study plan

Optical coherence tomography

Diagnostic Test

Posterior segment OCT (a non-contact procedure performed over one minute) is additionally performed for patients participating in this study. Proportion of change in measurements in microns will be analyzed.

Primary outcomes

  1. Macular thickness

    Time frame: 1 day after refractive procedure

    Proportion of Change in thickness of retina and its layers measured in microns

  2. Macular thickness

    Time frame: 1 week after refractive procedure

    Proportion of Change in thickness of retina and its layers measured in microns

Secondary outcomes

  1. Choroidal thickness

    Time frame: 1 day after refractive procedure

    Proportion of Change in thickness of choroid and its layers measured in microns

  2. Choroidal thickness

    Time frame: 1 week after refractive procedure

    Proportion of Change in thickness of choroid and its layers measured in microns

  3. visual acuity

    Time frame: 1 day after refractive procedure

    Proportion of Change in clarity of vision, measured in logarithm of Minimal Angle of Resolution (logMAR) units

  4. visual acuity

    Time frame: 1 week after refractive procedure

    Proportion of Change in clarity of vision, measured in logarithm of Minimal Angle of Resolution (logMAR) units

  5. central corneal thickness

    Time frame: 1 day after refractive procedure

    Proportion of Change in thickness of cornea measured in microns

  6. central corneal thickness

    Time frame: 1 week after refractive procedure

    Proportion of Change in thickness of cornea measured in microns

  7. anterior chamber depth

    Time frame: 1 day after refractive procedure

    Proportion of Change in depth of anterior chamber of the eye measured in microns

  8. anterior chamber depth

    Time frame: 1 week after refractive procedure

    Proportion of Change in depth of anterior chamber of the eye measured in microns

  9. keratometry

    Time frame: 1 day after refractive procedure

    Proportion of Change in corneal curvature measured in diopters

  10. keratometry

    Time frame: 1 week after refractive procedure

    Proportion of Change in corneal curvature measured in diopters

Study contacts

Contact information is provided by the study sponsor or research team.

Pukhraj P Rishi, MBBS

CONTACT

[email protected]

402-559-2020

Tolulope A Fashina, MD

CONTACT

[email protected]

4025591853

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

To Study the Effects of Refractive Surgery on Optical Coherence Tomography (OCT) Measurements in the Eye: A Pilot Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 12, 2023
Registry last updated
Mar 18, 2026

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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