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Набор по приглашению NCT07073937

Three Year Outcomes of Combined Hydrus Microstent With iTrack Canaloplasty

— Наблюдательное Glaucoma, Open Angle MIGS Minimally Invasive Glaucoma Surgery Canaloplasty

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: Retrospective chart review.
Кому может быть актуально
Состояния в реестре: Glaucoma, Open Angle, MIGS, Minimally Invasive Glaucoma Surgery, Canaloplasty. 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
США
Следующий шаг
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Обзор

The goal of this study is to learn if combining minimally invasive glaucoma surgery (MIGS) procedures with different mechanisms of action increases the effectiveness of MIGS. The main question the study aims to answer is: Does combining viscodilation (a surgical technique, often used in glaucoma treatment, that involves using a high-viscosity, elastic gel to widen and open the Schlemm's canal, a main drainage channel in the eye) with the iTrack catheter, along with the Hydrus microstent, show better reduction in intraocular pressure than cataract surgery alone? Researchers will retrospectively review charts of patients who have open-angle glaucoma who have undergone combination Hydrus implantation and 360-degree iTrack canaloplasty with concomitant cataract surgery, who have at least 36 months of clinical follow-up data. Baseline demographic information and severity of glaucoma will be recorded, as will change from baseline yearly to three years in average optical coherence tomography (OCT) retina nerve fiber layer (RNFL) measurements and visual field (VF) pattern standard deviation. Safety outcomes and the percentage of eyes requiring secondary surgical intervention will be recorded at yearly time points.

Вмешательства

  • Другое Retrospective chart review
    Retrospective study; a total of approximately 100 subjects have been identified to have had minimum 36 months follow-up.

Первичные конечные точки

  • Percentage of surgical success at three years. [Срок оценки: From baseline to three years post-surgery]
Вторичные конечные точки (8)
  • Mean decrease in IOP from baseline at three years [Срок оценки: From baseline to three years post-surgery]
  • Mean number of medication reduction from baseline to three years [Срок оценки: From baseline to three years post-surgery]
  • Percentage of eyes with greater than twenty percent reduction in IOP from baseline to year three [Срок оценки: From baseline to three years post-surgery]
  • Percentage of eyes that are medication free at three years [Срок оценки: At three years post-surgery]
  • Percentage of eyes with IOP between 14 and 18 mmHg on the same number of medications or fewer at three years post-surgery [Срок оценки: At three years post-surgery]
  • Change in average RNFL from baseline yearly to three years [Срок оценки: At baseline, one year, two years and three years post-surgery]
  • Change in average HVF PSD from baseline yearly to three years [Срок оценки: At baseline, one year, two years and three years post-surgery]
  • Percentage of eyes requiring secondary surgical intervention at yearly time points [Срок оценки: At one year, two years and three years post-surgery]

Критерии участия

Критерии включения

  • Patients with open angle glaucoma (mild, moderate or severe as defined below) who have undergone combined Hydrus and 360 degree canaloplasty with concomitant cataract surgery with at least 3-year follow-up data
  • Mild: Definite optic disc, RNFL, or macular imaging abnormalities consistent with glaucoma and a normal visual field as tested with standard automated perimetry (SAP)
  • Moderate: Definite optic disc, RNFL, or macular imaging abnormalities consistent with glaucoma, and visual field abnormalities in one hemifield that are not within 5 degrees of fixation as tested with SAP
  • Severe: Definite optic disc, RNFL, or macular imaging abnormalities consistent with glaucoma, and visual field abnormalities in both hemifields and/or loss within 5 degrees of fixation in at least one hemifield as tested with standard automated perimetry (SAP)
  • Patients who have had prior selective laser trabeculoplasty (SLT) are allowed

Критерии исключения

  • Prior corneal graft (penetrating Keratoplasty \[PKP\], deep anterior lamellar keratoplasty \[DALK\], Descemet's Stripping Automated Endothelial Keratoplasty \[DSAEK\], Descemet membrane endothelial keratoplasty \[DMEK\]) \& refractive surgery
  • Prior retinal surgery
  • Prior MIGS or incisional glaucoma surgery
  • Angle closure glaucoma and other secondary glaucoma

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 1 центр
  • University of Utah John A. Moran Eye Center — Salt Lake City

Идентификаторы

NCT: NCT07073937 · 186645

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗