Clinical trial NCT05856786: To Study the Effects of Refractive Surgery on OCT Measurements in the Eye
Official title: To Study the Effects of Refractive Surgery on Optical Coherence Tomography (OCT) Measurements in the Eye: A Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Optical Coherence Tomography
Refractive Errors
Myopia
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 33
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Macular thickness
timeFrame: 1 day after refractive procedure
measure: Macular thickness
timeFrame: 1 week after refractive procedure
Secondary outcomes:
measure: Choroidal thickness
timeFrame: 1 day after refractive procedure
measure: Choroidal thickness
timeFrame: 1 week after refractive procedure
measure: visual acuity
timeFrame: 1 day after refractive procedure
measure: visual acuity
timeFrame: 1 week after refractive procedure
measure: central corneal thickness
timeFrame: 1 day after refractive procedure
measure: central corneal thickness
timeFrame: 1 week after refractive procedure
measure: anterior chamber depth
timeFrame: 1 day after refractive procedure
measure: anterior chamber depth
timeFrame: 1 week after refractive procedure
measure: keratometry
timeFrame: 1 day after refractive procedure
measure: keratometry
timeFrame: 1 week after refractive procedure
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Unversity of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Pukhraj P Rishi, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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 Jul 7.
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. Epub 2022 Jan 5.