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

• Sponsor: University of Nebraska (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05856786
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Optical Coherence Tomography; Refractive Errors; Myopia	Diagnostic Test: Optical coherence tomography

Study Design

• Study Type: Observational
• Anticipated Enrollment: 33 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: To Study the Effects of Refractive Surgery on Optical Coherence Tomography (OCT) Measurements in the Eye: A Pilot Study
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Macular thickness [1 day after refractive procedure]

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

2. Macular thickness [1 week after refractive procedure]

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

Secondary Outcome Measures

1. Choroidal thickness [1 day after refractive procedure]

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

2. Choroidal thickness [1 week after refractive procedure]

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

3. visual acuity [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 [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 [1 day after refractive procedure]

   Proportion of Change in thickness of cornea measured in microns

6. central corneal thickness [1 week after refractive procedure]

   Proportion of Change in thickness of cornea measured in microns

7. anterior chamber depth [1 day after refractive procedure]

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

8. anterior chamber depth [1 week after refractive procedure]

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

9. keratometry [1 day after refractive procedure]

   Proportion of Change in corneal curvature measured in diopters

10. keratometry [1 week after refractive procedure]

    Proportion of Change in corneal curvature measured in diopters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nebraska Medical Centre	Omaha	Nebraska	United States	68105

Sponsors and Collaborators

• University of Nebraska

Investigators

• Principal Investigator: PUKHRAJ RISHI, MBBS, UNIVERSITY OF NEBRASKA MEDICAL CENTRE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pukhraj Rishi, Associate Professor, University of Nebraska
• ClinicalTrials.gov Identifier: NCT05856786
• Other Study ID Numbers: 0262-22-EP
• First Posted: May 12, 2023
• Last Update Posted: May 12, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Refractive Errors

Study Results

No Results Posted as of May 12, 2023