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Идёт набор NCT06607848

Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses

Без фазы С лечением Cataract

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: Low-Add EDOF IOL, EDOF IOL.
Кому может быть актуально
Состояния в реестре: Cataract. Базовые параметры: 21 лет — 105 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 →
Официальное название

Intraindividual Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses Set for Emmetropia

Обзор

Intra-individual comparison of the PureSee EDOF IOL with the Acunex Vario EDOF IOL set for emmetropia.

Подробное описание

Spectacle-independence is a growing goal in modern cataract surgery. The procedure has evolved from a simple restoration of vision to a presbyopia correction approach. Although bilateral monofocal IOL implantation with the goal of emmetropia results in high patient satisfaction for distance vision, spectacle-dependence for reading and intermediate vision tasks is the usual outcome.

Enhanced Depth of Focus (EDOF) lenses have been on the market for some time to minimize this spectacle-dependency in intermediate tasks (computer work, dashboard, etc.). These IOLs have an extended distance focal range that extends into the intermediate distance, providing high quality vision over a continuous focal range, rather than single foci with blurring in between. The risk to the patient is comparable to that of all other monofocal systems, which generally have high patient satisfaction. The benefit of this study should be continuous sharp binocular vision at distance, intermediate (66 cm) and even near (40 cm). Another expected effect is the reduction of dysphotopic phenomena compared to other EDOF lenses.

The aim of this study is to compare the visual performance of two refractive EDOF lenses, namely the Acunex Vario with the Puresee IOL, in an intraindividual comparative study design. In order to achieve a satisfactory result, we planned to include 40 patients scheduled for cataract surgery in the study.

The examinations will all take place one week before, 1 week and 4-6 months after the operation. These include a visual acuity check at the three distances mentioned, slit lamp examination, pressure control, biometry, pupil width, defocus curve, quality of vision questionnaires, contrast sensitivity, halo\&glare, optical coherence tomography, fundus examination, aberrometry and keratometry.

The main parameter to be examined is the distance-corrected visual acuity for the intermediate distance (66 cm) between the two IOLs at the follow-up examination after 4-6 months.

Вмешательства

  • Устройство Low-Add EDOF IOL
    Acunex Vario AN6V
  • Устройство EDOF IOL
    PureSee EDOF IOL

Первичные конечные точки

  • Distance corrected visual acuity for intermediate distance [Срок оценки: 6 months]
Вторичные конечные точки (7)
  • Uncorrected visual acuity for intermediate distance [Срок оценки: 6 months]
  • Uncorrected and distance corrected visual acuity for far distance [Срок оценки: 6 months]
  • Uncorrected and distance corrected visual acuity for near distance [Срок оценки: 6 months]
  • Defocus curve assessment [Срок оценки: 6 months]
  • Halometry [Срок оценки: 6 months]
  • Contrast sensitivity [Срок оценки: 6 months]
  • Subjective rating of dysphotopsia [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Age-related bilateral cataract
  • Age 21 or older
  • Visual acuity \> 0.05
  • For patients with regular corneal astigmatism greater than or equal to 1.00 dpt toric IOLs will be implanted
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically relevant
  • Written informed consent prior to surgery

Критерии исключения

  • Active ocular disease (e.g chronic uveitis, diabetic retinopathy, chronic glaucoma not responsive to medication, corneal dystrophies, etc.) precluding good post-operative visual acuity
  • Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX)
  • Corneal decompensation or corneal endothelial cell insufficiency
  • Irregular astigmatism on corneal tomography
  • Pronounced dry eye disease
  • Previous ocular surgery or trauma
  • Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Австрия · 1 центр
  • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna — Vienna

Идентификаторы

NCT: NCT06607848 · Vario vs. PureSee

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗