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Набор скоро начнётся NCT04817592

Characterization of the Corneal Biomechanics of Patients Treated by Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) to Correct Myopia

Наблюдательное Myopia

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: Corneal lenticule extraction for advanced refractive correction (CLEAR).
Кому может быть актуально
Состояния в реестре: Myopia. Базовые параметры: 20 лет — 50 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
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This study aims to perform biomechanical tests on extracted CLEAR lenticles that are routinely discarded after surgery. The investigators also aim to perform Brillouin microscopy to get an in-vivo assessment of the patient's cornea preoperatively and to correlate this data with the postoperative characterization of the extracted corneal lenticule. The characterization will be done with established biomechanical and morphologic tests.

Подробное описание

Refractive surgery techniques such as laser in situ keratomileusis (LASIK), corneal lenticule extraction (SMILE/CLEAR) and photorefractive keratectomy (PRK) are becoming increasingly popular among myopic patients. With current surgical planning tools, there is a reported 10-15 % chance of over/under correction, in particular with higher corrections. The biggest factor that leads to this discrepancy is the "one size fits all" approach. Patient specific characteristics of the eye such as the corneal material properties, are not considered in the surgical planning. This information is also essential for diagnosis and treatment of pathologies like keratoconus. New diagnostics devices based on e. g. Brillouin scattering are now introduced on the market, with the aim to provide an in-vivo quantification of the biomechanical tissue properties. However, the relationship between the Brillouin measurement and the biomechanical properties of the cornea is not fully understood yet. The investigators aim for determining an improved relationship between the optical Brillouin measurement performed in-vivo preoperatively and classical destructive biomechanical testing of the extracted corneal lenticule after the surgery. This lenticule is currently discarded after surgery.

The purpose of the study is to investigate the exact relationship between the classically determined material properties (by stress-/strain measurements) and optically obtained data by Brillouin scattering, which are collected during pre-op investigations. A precise characterization and relation between both measurements will allow clinicians to better predict surgical parameters and perform better refractive interventions. This information will also inform clinicians on the mechanical status of the cornea of patients suffering from subclinical keratoconus.

Вмешательства

  • Процедура Corneal lenticule extraction for advanced refractive correction (CLEAR)
    Routinely conducted procedure for correction of Myopia

Первичные конечные точки

  • Biomechanics of extracted lenticule [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Patients scheduled for CLEAR procedures for myopia (range: >-3D with an astigmatism <0.25D) in the age group 20-50 years.
  • Willing and able to return for scheduled follow-up examinations
  • Able to provide written informed consent and follow study instructions in English or German

Критерии исключения

  • Irregular corneal topo-/tomography (Asymmetry >1.0D within the inner 5mm)
  • Previous intraocular or corneal surgery of any kind in the eye to be treated, including any type of surgery for either refractive or therapeutic purposes.
  • History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative intraocular pressure (IOP) > 21 mmHg in either eye.
  • History of diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 1 центр
  • IROC AG — Zurich

Идентификаторы

NCT: NCT04817592 · Basec Nr 2021-001-45

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗