Evaluation of Microinvasive Glaucoma Surgery: MINIject® Versus Hydrus® Microstent in Combination With Cataract Surgery
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: MINIject with Cataract Surgery, Hydrus Microstent with Cataract Surgery.
- Кому может быть актуально
- Состояния в реестре: Glaucoma, Cataract. 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
- Австрия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The study aims to investigate postoperative outcomes after two different MIGS implants (MINIject or Hydrus) in combination with cataract surgery for patients with glaucoma.
Подробное описание
The study aims to investigate postoperative outcomes in terms of intraocular pressure as well as safety measures after two different MIGS implants (MINIject® or Hydrus®) in conjunction with cataract surgery (CS) for patients with chronic glaucoma. The patients will be followed up for 5 years after the date of their implantation. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination and ocular imaging with OCT (Optical Coherence Tomography). Assessment of life quality as well as adverse events will be performed.
Вмешательства
- Устройство MINIject with Cataract Surgery
Patients will be randomized to receive either a MINIject implant or a Hydrus Microstunt in conjunction with cataract surgery. If randomized to MINIject, the device will be implanted into the supraciliary space with a minimally invasive ab interno approach. It is designed to be implanted with its head in the anterior chamber and its body in the supraciliary space, leading to improved natural uveoscleral outflow by directing aqueous humor from the anterior chamber to the sub-scleral space. Catarac - Устройство Hydrus Microstent with Cataract Surgery
Patients will be randomized to receive either a Hydrus Microstunt or a MINIject implant in conjunction with cataract surgery. If randomized to Hydrus Microstent, the device will be implanted into Schlemm's canal through the trabecular meshwork in order to dilate and restore the natural aqueous outflow pathway through Schlemm's canal, leading to a reduction of intraocular pressure. Cataract surgery will be performed with phacoemulsification.
Первичные конечные точки
- Intraocular Pressure After Surgery [Срок оценки: Baseline visit to 1 year]
Вторичные конечные точки (12)
- Intraocular Pressure at Other Follow-Up Time Points [Срок оценки: Baseline visit to 5 years]
- Anti-Hypertensive Medications Required [Срок оценки: Baseline visit and week 1, month 1/3/6 and year 1/2/3/4/5]
- Best Corrected Visual Acuity [Срок оценки: Baseline visit and week 1, month 1/3/6 and year 1/2/3/4/5]
- Complete Success [Срок оценки: Baseline visit and visit at month 3/6 and year 1/2/3/4/5]
- Qualified Success [Срок оценки: Baseline visit and visit at month 3/6 and year 1/2/3/4/5]
- Endothelial Cell Density [Срок оценки: Baseline visit and visit at year 1/2/3/4/5]
- Assessment of Life Quality - Glaucoma Quality of Life-15 Questionnaire [Срок оценки: Baseline visit and visit at month 6 and year 1/2/3/4/5]
- Assessment of Life Quality - Ocular Surface Disease Index [Срок оценки: Baseline visit and visit at month 6 and year 1/2/3/4/5]
- Rate of Additional Ocular Surgery Post-Implantation [Срок оценки: 5 years]
- Rate of Complications or Incidents [Срок оценки: 5 years]
- Data From Optical Biometry - Axial Length [Срок оценки: Baseline visit and year 1 visit]
- Data From Optical Biometry - Anterior Chamber Depth [Срок оценки: Baseline visit and year 1 visit]
Критерии участия
Критерии включения
- Patients with glaucoma in which surgery is indicated to reach target intraocular pressure as well as lens opacities where CS is indicated
- Clinically eligible for both surgeries
- Subjects not anticipated to require any further surgery in the next 12 months
- Patients' age > 18 years
Критерии исключения
- Patients who do not want to make follow-ups at the department
- Angle closure, uveitic, neovascular, congenital glaucoma, iridocorneal endothelial syndrome, Axenfeld-Rieger syndrome
- Prior filtering glaucoma surgery, suprachoroidal stent, retinal surgery, corneal graft surgery or cyclophotocoagulation
- Allergy to any drugs or substances required for the protocol
- Pregnant women
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
- Открытое
- Основная цель
- Лечение
Центры проведения
Австрия · 1 центр
- Medical University Graz — Graz
Идентификаторы
NCT: NCT06844292 · 1242/2024