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Идёт набор NCT07074431

"Comparative Study of High-frequency Pulsed Vacuum Technology Versus Phacoemulsification for Cataract Surgery

Без фазы С лечением Cataract Bilateral

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: EYE 1 SURGERY BY CATAPULSE TECHNIC, EYE 2 SURGERY BY CATAPULSE TECHNIC.
Кому может быть актуально
Состояния в реестре: Cataract Bilateral. Базовые параметры: от 18 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Cataracts are cloudings of the lens, primarily due to aging. Surgery is the primary treatment for cataracts. The most commonly used surgical technique is phacoemulsification, which involves fragmenting the lens using a high-frequency ultrasound probe and removing the fragments. Phacoemulsification is more common due to its advantages. Recently, a new approach has emerged, using high-frequency pulsed vacuum technology for cataract ablation. This less invasive approach is expected to allow for faster patient recovery and reduce surgical risks. High-frequency pulsed vacuum utilizes the pulse-pulse principle by interrupting the vacuum every tenth of a second. This interruption creates an impact moment between the cataract material and the cannula tip, dissecting the cataract without damaging the surrounding delicate tissue. High-frequency pulsed vacuum maintains anterior chamber stability while creating sufficient dissection to aspirate the cataract material. This energy also cools the tip, allows for better vacuum control, and significantly reduces turbulence within the eye. More importantly, high-frequency pulsed vacuum disrupts endothelial cells less and causes less edema than mechanical ultrasound. This technique therefore appears ideal for treating patients with at-risk corneas (low endothelial cell count, risk of decompensation and corneal transplantation). The objective of the study is to demonstrate the benefits of this approach using high-frequency pulsed vacuum technology through a randomized, comparative, crossover study.

Вмешательства

  • Процедура EYE 1 SURGERY BY CATAPULSE TECHNIC
    In arm 2: 1st eye operated by high-frequency pulsed vacuum technology / 2nd eye operated by phacoemulsification
  • Процедура EYE 2 SURGERY BY CATAPULSE TECHNIC
    In arm 1: 1st eye operated by phacoemulsification / 2nd eye operated by high-frequency pulsed vacuum technology

Первичные конечные точки

  • Endothelial cell count by specular microscopy after each surgery [Срок оценки: At Day30 (+/- 7 days)]
Вторичные конечные точки (7)
  • Visual acuity [Срок оценки: before each procedure, between day 1 and day 5 after each procedure, and day 30 (+/- 7 days) after each procedure]
  • Measurement of postoperative inflammation [Срок оценки: Between Day 1 and Day 5 after each cataract surgery]
  • The rate of postoperative complications [Срок оценки: Between Day 1 and Day 5 after each cataract surgery, at Day30 (+/- 7 days)]
  • The operating times of each surgery [Срок оценки: Perioperative]
  • Satisfaction with the use of high-frequency pulsed vacuum technology by healthcare teams [Срок оценки: Between Day 1 and Day 5 after each cataract surgery with CATAPULSE]
  • A Likert scale will be used to assess patient comfort during surgery [Срок оценки: Between Day 1 and Day 5 after each cataract surgery]
  • Adverse events related to both surgeries [Срок оценки: Between Day 1 and Day 5 after each cataract surgery and at Day30 (+/- 7 days)]

Критерии участия

Критерии включения

  • Adult patient
  • Patient with bilateral cataracts
  • Grade 1 to 3 cataracts
  • Indication for bilateral cataract surgery
  • Patient informed of the study and having given their written and signed informed consent
  • Patient affiliated with a social security scheme or beneficiary of such a scheme

Критерии исключения

  • Refusal of consent
  • Cataract grade > 3
  • Unilateral and/or combined cataract surgery
  • Uveitic cataract
  • Glaucoma
  • Patient with ocular comorbidity
  • Patient with cognitive impairment preventing them from responding to satisfaction questionnaires
  • Patient unable to read, write, or understand French
  • Pregnant or breastfeeding patient as defined in Article L1121-5 of the French Public Health Code
  • Vulnerable patient as defined in Article L1121-6 of the French Public Health Code
  • Adult patient under guardianship, curatorship, or legal protection
  • Patient unable to give personal consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Франция · 1 центр
  • Clinique Victor Pauchet — Amiens

Идентификаторы

NCT: NCT07074431 · 2024-A02793-44

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗