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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Refractive Errors; Myopia; Optical Coherence Tomography
• Intervention / Treatment: Diagnostic test: Optical coherence tomography

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 33

Contacts and Locations

• Study Contact: Name: Pukhraj P Rishi, MBBS; Phone Number: 402-559-2020; Email: pukhraj.rishi@unmc.edu
• Study Contact Backup: Name: Tolulope A Fashina, MD; Phone Number: 4025591853; Email: tfashina@unmc.edu

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Recruiting
      • Unversity of Nebraska Medical Center
      • Contact: Pukhraj P Rishi, MBBS; Phone Number: 402-559-2020; Email: pukhraj.rishi@unmc.edu
      • Contact: Tolulope A Fashina, MD; Phone Number: 402-559-1853; Email: tfashina@unmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

All subjects in the study will be adults aged 19 years or more, that fits the typical age profile of patients in the refractive surgery clinic. Refractive surgery is an elective surgery and the patients are encouraged to ask questions about the study. This is an observational study and all aspects of care, including procedures, visits, and exams, carried out as part of the study represent standard of care. Patients visiting the refractive surgery clinic will be given an option to participate in the study if they meet the selection criteria. The clinical care of the patient will not be affected by the patient's participation or non-participation in the study.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Astigmatism more than 3 Diopters
2. Visual acuity worse than 20/25
3. Patients with unstable visual fixation
4. Severe Dry Eye

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ocular parameters; Patients aged 19 years or more who are scheduled to undergo refractive surgery will be included in the study. OCT will be performed at baseline (before surgery), 1 day after surgery and 1 week after surgery. Each patient will be tested 3 times.	Diagnostic test: Optical coherence tomography; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular thickness	Proportion of Change in thickness of retina and its layers measured in microns	1 day after refractive procedure
Macular thickness	Proportion of Change in thickness of retina and its layers measured in microns	1 week after refractive procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Choroidal thickness	Proportion of Change in thickness of choroid and its layers measured in microns	1 day after refractive procedure
Choroidal thickness	Proportion of Change in thickness of choroid and its layers measured in microns	1 week after refractive procedure
visual acuity	Proportion of Change in clarity of vision, measured in logarithm of Minimal Angle of Resolution (logMAR) units	1 day after refractive procedure
visual acuity	Proportion of Change in clarity of vision, measured in logarithm of Minimal Angle of Resolution (logMAR) units	1 week after refractive procedure
central corneal thickness	Proportion of Change in thickness of cornea measured in microns	1 day after refractive procedure
central corneal thickness	Proportion of Change in thickness of cornea measured in microns	1 week after refractive procedure
anterior chamber depth	Proportion of Change in depth of anterior chamber of the eye measured in microns	1 day after refractive procedure
anterior chamber depth	Proportion of Change in depth of anterior chamber of the eye measured in microns	1 week after refractive procedure
keratometry	Proportion of Change in corneal curvature measured in diopters	1 day after refractive procedure
keratometry	Proportion of Change in corneal curvature measured in diopters	1 week after refractive procedure

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Pukhraj P Rishi, MBBS, University of Nebraska

Publications and helpful links

General Publications

• Chen Y, Liao H, Sun Y, Shen X. Short-term changes in the anterior segment and retina after small incision lenticule extraction. BMC Ophthalmol. 2020 Oct 7;20(1):397. doi: 10.1186/s12886-020-01668-7.
• Shpak AA, Kostenev SV, Mushkova IA, Korobkova MV. [Effect of corneal refractive surgery on optical coherence tomography measurements]. Vestn Oftalmol. 2018;134(5):48-53. doi: 10.17116/oftalma201813405148. Russian.
• Ozsaygili C, Altunel O, Duru N. Evaluation of the change in retinal thickness after femtosecond laser-assisted laser in situ keratomileusis and photorefractive keratectomy. Curr Eye Res. 2022 Jan;47(1):18-24. doi: 10.1080/02713683.2021.1951297. Epub 2021 Jul 7.
• Yalcinkaya G, Yildiz BK, Cakir I, Yildirim Y, Demirok A. Evaluation of peripapillary - macular microvascularity and choroidal vascularity index after refractive surgery. Photodiagnosis Photodyn Ther. 2022 Mar;37:102714. doi: 10.1016/j.pdpdt.2022.102714. Epub 2022 Jan 5.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Myopia; Refractive Errors; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Tomography, Optical; Optical Imaging; Tomography, Optical Coherence
• Other Study ID Numbers: 0262-22-EP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No