To Study the Effects of Refractive Surgery on OCT Measurements in the Eye
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Optical coherence tomography.
- Who it may be relevant to
- Registry conditions: Optical Coherence Tomography, Refractive Errors, Myopia. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
To Study the Effects of Refractive Surgery on Optical Coherence Tomography (OCT) Measurements in the Eye: A Pilot Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Macular thickness [Time frame: 1 day after refractive procedure]
- Macular thickness [Time frame: 1 week after refractive procedure]
Secondary outcome measures (10)
- Choroidal thickness [Time frame: 1 day after refractive procedure]
- Choroidal thickness [Time frame: 1 week after refractive procedure]
- visual acuity [Time frame: 1 day after refractive procedure]
- visual acuity [Time frame: 1 week after refractive procedure]
- central corneal thickness [Time frame: 1 day after refractive procedure]
- central corneal thickness [Time frame: 1 week after refractive procedure]
- anterior chamber depth [Time frame: 1 day after refractive procedure]
- anterior chamber depth [Time frame: 1 week after refractive procedure]
- keratometry [Time frame: 1 day after refractive procedure]
- keratometry [Time frame: 1 week after refractive procedure]
Eligibility criteria
Inclusion criteria
- Patients undergoing refractive surgery
- For patients undergoing bilateral eye surgery, the one with higher degree of ametropia will be included.
Exclusion criteria
- Astigmatism more than 3 Diopters
- Visual acuity worse than 20/25
- Patients with unstable visual fixation
- Severe Dry Eye
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Unversity of Nebraska Medical Center — Omaha
Publications
- 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. PMID 33028265
- 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. PMID 30499539
- 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. PMID 34231433
- 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. PMID 34995787
Identifiers
NCT: NCT05856786 · 0262-22-EP