INTEGRAL Study: A Longitudinal Study of Surgeries and Lasers in Glaucoma: Long-term Results and Success Predictors Analysed From a Large-scale Retrospective and Prospective Glaucoma Register
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Glaucoma Open-Angle, Glaucoma Eye, Glaucoma; Drugs, Glaucoma, Angle-Closure. Базовые параметры: 1 год — 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
- Швейцария
- 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 is an observational analysis of patients' medical data recorded in a large-scale register, both retrospective (for patients operated and data recorded before 2018) and prospective (for data collected after 2018) in nature.Patients' medical data contained in the register will be analysed to determine the efficacy of the treatments they received during their follow-up at the investigation centre.
Подробное описание
This study involves the creation and analysis of a large-scale register including all patients suffering from glaucoma, currently and previously followed-up and treated at a single tertiary centre in Lausanne, Switzerland. The design of the study is longitudinal, observational and comparative. Patients are recruited retrospectively if they attended the research centre before September 2018, and prospectively if they attend the centre from this month onwards. Their inclusion does not affect their care, treatment choice or follow-up. All data of recruited patients is be kept in their medical notes until a specific analysis is launched. Data is then exported from their medical notes into a coded database for analysis. At the end of each analysis session (defined as the publication of the related article), all exported data is fully anonymised.
Data analysis will aim to assess the long-term efficacy, safety profile, and factors predictive of success/failure of treatments performed.
To ensure the quality of all included data, health-related information will be extracted directly from the medical notes and coded into the register by a Clinical Research Associate. Conformity of the process and recorded data will be confirmed by regular internal auditing. For quality assurance the Ethics Committee may visit the research sites. Direct access to the source data and all project related files and documents must be granted on such occasions.
Первичные конечные точки
- Number of patients with IOP reduction mmHg [Срок оценки: 12 month]
- Patients with quantitative OCT variations ( RNFL, μm) [Срок оценки: 12 month]
- Number of patients with quantitative VF variation ( MD, dB) [Срок оценки: 12 month]
- Number of patients with quantitative VF variation (LV, dB) [Срок оценки: 12 months]
Вторичные конечные точки (6)
- Number of operations received by a patients [Срок оценки: 12 month]
- Number of patients undergoing a specific ocular surgical or laser procedure [Срок оценки: 12 month]
- Number of lowering IOP drugs ( molecules) taken by each patient [Срок оценки: 12 month]
- Anterior segment OCT variations: ACA (°), SSA (°) [Срок оценки: 12 month]
- Anterior segment OCT variations: AOD (mm) [Срок оценки: 12 month]
- Anterior segment OCT variations: TISA (mm2) [Срок оценки: 12 month]
Критерии участия
Критерии включения
- Diagnosis of glaucoma (open-angle, closed-angle, primary or secondary) or ocular hypertension (IOP > 24 mmHg, medicated or not)
- Patients who received treatment (medical, laser or surgical) at the Glaucoma Centre, Montchoisi Clinic
- Able and willing to provide informed written or verbal consent
Критерии исключения
- Patient who are unable to understand the implications of their inclusion in the study or who are unable or unwilling to give informed consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Швейцария · 1 центр
- SwissVisio Montchoisi — Lausanne
Публикации
- Meduri E, Gillmann K, Bravetti GE, Niegowski LJ, Mermoud A, Weinreb RN, Mansouri K. Iridocorneal Angle Assessment After Laser Iridotomy With Swept-source Optical Coherence Tomography. J Glaucoma. 2020 Nov;29(11):1030-1035. doi: 10.1097/IJG.0000000000001654. PMID 32890108
Идентификаторы
NCT: NCT04381611 · INTEGRAL