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Идёт набор NCT05822089

Intraindividual Comparison of EMO IOLs

Без фазы С лечением Age Related Cataracts

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Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: phacoemulsification and intraocular lens implantation, phacoemulsification and intraocular lens implantation, phacoemulsification and intraocular lens implantation, phacoemulsification and intraocular lens implantation.
Кому может быть актуально
Состояния в реестре: Age Related Cataracts. Базовые параметры: 50 лет — 100 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
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Официальное название

Comparison of Visual Outcomes of Enhanced Monofocal Intraocular Lenses

Обзор

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.

Вмешательства

  • Процедура phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00)
  • Процедура phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Sensar 1 AAB00) vs. an enhanced monofocal IOL (ICB00)
  • Процедура phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Vivinex XY1) vs. an enhanced monofocal IOL (Vivinex impress)
  • Процедура phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Vivinex impress) in both eyes
  • Процедура phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart)
  • Процедура phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an extended depth of focus IOL (Acrysof IQ Vivity) in both eyes if low to moderate irregular astigmatism is observed
  • Процедура phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an extended depth of focus IOL (IC-8 Apthera) in one eye if irregular astigmatism is observed
  • Процедура phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (EnVista) vs. an enhanced monofocal IOL (EnVista Aspire)
  • Процедура phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced depth of focus IOL (PureSee) in both eyes
  • Процедура phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Vivinex XY1) in both eyes or a monofocal IOL (Vivinex XC1) in both eyes

Первичные конечные точки

  • Distant corrected intermediate visual acuity [Срок оценки: 2-6 months]
  • Best-corrected distance visual acuity (BCDVA) - Acrysof IQ Vivity IOL, IC-8 Apthera IOL [Срок оценки: 3-5 months]
  • Contrast sensitivity and reading ability - Vivinex XC1 and Vivinex XY1 [Срок оценки: 2-6 months and 1-5 years]
Вторичные конечные точки (1)
  • Contrast sensitivity and reading ability [Срок оценки: 2-6 months and 1-5 years]

Критерии участия

Критерии включения

  • Bilateral age-related cataract planned for phacoemulsification extraction and posterior IOL implantation
  • Age 50 to 100
  • Visual potential in both eyes of 20/25 or better as determined by investigators estimation
  • Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Irregular Astigmatism (Acrysof IQ Vivity IOL, IC-8 Apthera IOL)
  • postoperativ binocular best corrected distance visual acuity (BCVA) ≥ 1.0 decimal (Arm ten (X))
  • Standard cataract surgery with bilateral implantation of a monofocal IOL (Vivinex XC1 or Vivinex XY1) (Arm ten (X))

Критерии исключения

  • Preceding intraocular surgery or ocular trauma
  • Relevant other ophthalmic diseases that particularly effects the zonular apparatus (such as severe pseudoexfoliation syndrome, preceding cryocoagulation, trauma)
  • Pupil diameter < 2.0 mm (photopic)
  • Laser treatment
  • Uncontrolled systemic or ocular disease
  • Pregnancy/Nursing
  • childbearing ability

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Австрия · 1 центр
  • Medical University of Vienna — Vienna

Идентификаторы

NCT: NCT05822089 · 1631/2021

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗