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

NCT ID: NCT05856786

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Optical Coherence Tomography; Refractive Errors; Myopia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Optical coherence tomography

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pukhraj P Rishi, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Unversity of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pukhraj P Rishi, MBBS

Role: CONTACT

pukhraj.rishi@unmc.edu

402-559-2020

Tolulope A Fashina, MD

Role: CONTACT

tfashina@unmc.edu

4025591853

Facility Contacts

Pukhraj P Rishi, MBBS

Role: primary

pukhraj.rishi@unmc.edu

402-559-2020

Tolulope A Fashina, MD

Role: backup

tfashina@unmc.edu

402-559-1853

References

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.

Reference Type: BACKGROUND

PMID: 33028265 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30499539 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34231433 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34995787 (View on PubMed)

Other Identifiers

0262-22-EP

Identifier Type: -

Identifier Source: org_study_id