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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05856786
• Other study ID #: 0262-22-EP
• Status: Recruiting
• Start date: June 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Nebraska
• Contact: Pukhraj P Rishi, MBBS
• Phone: 402-559-2020
• Email: pukhraj.rishi[@]unmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myopia
• Optical Coherence Tomography
• Refractive Errors

Intervention

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.

Locations

Country	Name	City	State
United States	Unversity of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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 — View Citation

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. — View Citation

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. E — View Citation

Outcome

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