To Study the Effects of Refractive Surgery on OCT Measurements in the Eye
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Optical coherence tomography.
- Кому может быть актуально
- Состояния в реестре: Optical Coherence Tomography, Refractive Errors, Myopia. Базовые параметры: от 19 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
To Study the Effects of Refractive Surgery on Optical Coherence Tomography (OCT) Measurements in the Eye: A Pilot Study
Обзор
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.
Подробное описание
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.
Вмешательства
- Диагностический тест 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.
Первичные конечные точки
- Macular thickness [Срок оценки: 1 day after refractive procedure]
- Macular thickness [Срок оценки: 1 week after refractive procedure]
Вторичные конечные точки (10)
- Choroidal thickness [Срок оценки: 1 day after refractive procedure]
- Choroidal thickness [Срок оценки: 1 week after refractive procedure]
- visual acuity [Срок оценки: 1 day after refractive procedure]
- visual acuity [Срок оценки: 1 week after refractive procedure]
- central corneal thickness [Срок оценки: 1 day after refractive procedure]
- central corneal thickness [Срок оценки: 1 week after refractive procedure]
- anterior chamber depth [Срок оценки: 1 day after refractive procedure]
- anterior chamber depth [Срок оценки: 1 week after refractive procedure]
- keratometry [Срок оценки: 1 day after refractive procedure]
- keratometry [Срок оценки: 1 week after refractive procedure]
Критерии участия
Критерии включения
- Patients undergoing refractive surgery
- For patients undergoing bilateral eye surgery, the one with higher degree of ametropia will be included.
Критерии исключения
- Astigmatism more than 3 Diopters
- Visual acuity worse than 20/25
- Patients with unstable visual fixation
- Severe Dry Eye
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Unversity of Nebraska Medical Center — Omaha
Публикации
- 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
Идентификаторы
NCT: NCT05856786 · 0262-22-EP