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

Recruiting

• Conditions: Optical Coherence Tomography; Refractive Errors; Myopia
• Interventions: Diagnostic Test: Optical coherence tomography

• Registration Number: NCT05856786
• Lead Sponsor: University of Nebraska

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.

Study Timeline

• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-12
• Study Start: 2024-06-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2025-01-01
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ocular parameters	Optical coherence tomography	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.

Primary Outcome Measures

Name	Time	Method
Macular thickness	1 week after refractive procedure	Proportion of Change in thickness of retina and its layers measured in microns

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Unversity of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States