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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical coherence tomography | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Macular thickness | Proportion of Change in thickness of retina and its layers measured in microns | 1 day after refractive procedure |
| Macular thickness | Proportion of Change in thickness of retina and its layers measured in microns | 1 week after refractive procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Choroidal thickness | Proportion of Change in thickness of choroid and its layers measured in microns | 1 day after refractive procedure |
| Choroidal thickness | Proportion of Change in thickness of choroid and its layers measured in microns |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pukhraj P Rishi, MBBS | Contact | 402-559-2020 | pukhraj.rishi@unmc.edu | |
| Tolulope A Fashina, MD | Contact | 4025591853 | tfashina@unmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pukhraj P Rishi, MBBS | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unversity of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33028265 | Background | 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. | |
| 30499539 | Background | 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. |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| 1 week after refractive procedure |
| visual acuity | Proportion of Change in clarity of vision, measured in logarithm of Minimal Angle of Resolution (logMAR) units | 1 day after refractive procedure |
| visual acuity | Proportion of Change in clarity of vision, measured in logarithm of Minimal Angle of Resolution (logMAR) units | 1 week after refractive procedure |
| central corneal thickness | Proportion of Change in thickness of cornea measured in microns | 1 day after refractive procedure |
| central corneal thickness | Proportion of Change in thickness of cornea measured in microns | 1 week after refractive procedure |
| anterior chamber depth | Proportion of Change in depth of anterior chamber of the eye measured in microns | 1 day after refractive procedure |
| anterior chamber depth | Proportion of Change in depth of anterior chamber of the eye measured in microns | 1 week after refractive procedure |
| keratometry | Proportion of Change in corneal curvature measured in diopters | 1 day after refractive procedure |
| keratometry | Proportion of Change in corneal curvature measured in diopters | 1 week after refractive procedure |
| 34231433 | Background | 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. |
| 34995787 | Background | 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. |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |