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

NCT05856786 | Recruiting DMC

• 1 other identifier: 0262-22-EP
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Optical Coherence Tomography; Refractive Errors; Myopia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Choroidal thickness

  1 day after refractive procedure

• Choroidal thickness

  1 week after refractive procedure

• visual acuity

  1 day after refractive procedure

• visual acuity

  1 week after refractive procedure

• central corneal thickness

  1 day after refractive procedure

Study Arms (1)

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

Interventions

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.

Ocular parameters

Eligibility Criteria

• Age: 19 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68105, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 33028265 BACKGROUND

• 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.

  PMID: 30499539 BACKGROUND

• 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.

  PMID: 34231433 BACKGROUND

• 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.

  PMID: 34995787 BACKGROUND

MeSH Terms

Conditions

Refractive Errors; Myopia

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Pukhraj P Rishi, MBBS

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pukhraj P Rishi, MBBS

CONTACT

402-559-2020; pukhraj.rishi@unmc.edu

Tolulope A Fashina, MD

CONTACT

4025591853; tfashina@unmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 12, 2023
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)