Pseudophakic Eyes With Presbyopia-correcting IOLs: OCT Biometry and Pyramid Aberrometry
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: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy).
- Кому может быть актуально
- Состояния в реестре: Cataract. Базовые параметры: 21 лет — 110 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
- Австрия
- 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
Pseudophakic Eyes Implanted With Different Presbyopia-correcting IOL Designs: 3-D Anterior Segment OCT Biometry and Pyramid Wavefront Sensing- Based Retinal Image Quality
Обзор
To correlate ocular morphology from anterior segment OCT and pyramid wavefront sensing in order to comprehensively analyze pseudophakic in vivo image quality of presbyopia-correcting IOLs in cataract patients.
Подробное описание
Improvements in cataract surgery and the introduction of different intraocular lenses (IOLs) have transformed the operation from a simple therapeutic procedure to a refractive surgical procedure. A large number of currently available IOL designs are not limited to correcting refractive errors and astigmatism, but can also compensate for corneal sphericity and/or moderate presbyopia by inducing multifocality or extending the depth of focus.
The three-dimensional representation of the anterior segment of the eye has been facilitated in eye surgery by the introduction of optical coherence tomography (OCT), and imaging techniques such as spectral domain OCT (SD-OCT) and swept-source OCT (SS OCT) are particularly well suited for the quantitative characterization of eye dimensions. This offers the possibility of creating biometric eye models and using the non-paraxial regime for characterizing eye optics.
Similarly, the introduction of ocular wavefront aberrometry at the turn of the millennium led to a paradigm shift in the evaluation of clinical optical imaging quality and the derivation of objective optical metrics. Furthermore, internal lens aberrations can be quantified by direct subtraction from anterior segment tomography. However, high-resolution eye tomography and wavefront aberrometry are rarely comprehensively linked.
A pyramidal wavefront sensor (PWS) Osiris-T (CSO, Italy) was recently introduced, which can measure the ocular wavefront with a significantly higher lateral resolution. In addition, tomographic parameters of the anterior segment can be imported directly into the device to examine the clinical optical performance of IOL implants. This provides the ability to combine 3-D OCT biometry of the anterior segment and high-resolution wavefront aberrometry.
A total of 160 eyes of 80 patients will be included.
Вмешательства
- Устройство Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)
The Osiris-T aberrometer is a CE-certified device that operates via a high-resolution four-faced pyramid wavefront sensor (PWS) to analyze light intensity among four images (sub-apertures) of the patients ́entrance pupil akin to a Foucault knife-edge test. Thereby measurements of the wavefront and refractive error can be quantified non-invasively. The sampling density of the wavefront error is 45,000 points at maximum pupil. The device uses a near-infrared extended light-emitting diode source em
Первичные конечные точки
- IOL ocular optics measument [Срок оценки: 24 months]
Вторичные конечные точки (4)
- Comparison of clinical optical quality and device measurements [Срок оценки: 24 months]
- Higher-order aberrations in non-dilated and dilated pupils [Срок оценки: 24 months]
- Non-dilated and dilated Pupil centration [Срок оценки: 24 months]
- Correlation and Comparison of IOL decentration [Срок оценки: 24 months]
Критерии участия
Критерии включения
- Men and women aged above 21 years with prior uncomplicated cataract/IOL exchange surgery
- Willing to sign informed consent before measurements
- Corrected distance visual acuity (CDVA) of 0.1 logMAR or better
- Absence of corneal scars/dry eye disease that could falsify the light transmission of the study eye
- Total absence of posterior capsule opacification or patients who already have undergone Nd:YAG capsulotomy
- Absence of ocular comorbidity (Macular degeneration, glaucoma, amblyopia)
Критерии исключения
- Prior corneal refractive or ocular surgery
- Posterior capsule opacification.
- Keratometry between <42.5 and >45 D,
- Corneal spherical aberration > 0.4 microns 5) Angle kappa > 0.4 mm
6\) Zonular weakness 7) Pseudoexfoliation syndrome 8) Eccentric fixation or insufficient ability to fixate (tremor, nystagmus) 9) Pregnancy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Австрия · 2 центра
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna — Vienna
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna — Vienna
Идентификаторы
NCT: NCT07436247 · IOLs and pyramid aberrometry