Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial
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: SLT.
- Кому может быть актуально
- Состояния в реестре: Glaucoma, Open-Angle, Pseudoexfoliation Glaucoma, Ocular Hypertension. 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
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Glaucoma is a common eye disease that can lead to blindness. The only known way to reduce the rate of disease progression is by reducing the pressure in the eye (the intraocular pressure, IOP). Selective laser trabeculoplasty (SLT) is an ophthalmic laser intervention with the purpose of reducing the IOP. SLT can be performed in different ways, with four of the treatment protocols being evaluated in the Optimal SLT (OSLT) trial. SLT is a repeatable procedure, but scientific evidence is scarce regarding more than one repetition. In this trial, patients included in the OSLT trial will be invited to the extended trial (OSLT-R), for further follow-up and re-treatment with SLT, if needed.
Подробное описание
Subjects already included in the OSLT trial (NCT03798223) will be invited to the extended trial (OSLT-R) at the time of SLT re-treatment or when OSLT follow up is scheduled to terminate. Patients are re-treated as needed, according to the randomized group assignment performed in the OSLT inclusion process.
The OSLT-R trial is aiming to elucidate:
* If the SLT efficacy, in terms of relative IOP reduction (percent of baseline IOP), changes with additional SLT iterations. * If the longevity of IOP reduction after SLT changes with additional SLT iterations. * If repeated SLT is associated with a change in postoperative discomfort or adverse events.
All of the above will be analyzed within each of the four treatment groups (SLT protocols) in the trial. Further, analysis will also be conducted regarding differences between the treatment groups regarding the above.
Further, analysis will be performed regarding SLT efficacy depending of the total number of SLT:s an eye has received, including those performed before entering the OSLT and OSLT-R trials.
Вмешательства
- Процедура SLT
A drop of Pilocarpine 4% is administered to the eye 20 minutes before SLT. Immediately before SLT a drop of Tetracaine hydrochloride 1% is administered. Selective laser trabeculoplasty is conducted through a Latina lens, in a fashion determined by randomization to a study arm (see description).
Первичные конечные точки
- Relative IOP reduction for each SLT iteration [Срок оценки: 1-6 months after each SLT, as described above]
Вторичные конечные точки (10)
- Survival (for each SLT iteration) [Срок оценки: From randomization to failure (IOP lowering intervention, except repeat SLT) or censoring (death, patients choice), assessed until the last of: 1. 3 years after randomization; 2. 31 Dec 2024 or; 3. Six months after the last SLT during that timespan.]
- Survival (repeat SLT allowed) [Срок оценки: From each SLT iteration to failure (IOP lowering intervention incl. repeat SLT) or censoring (death, patients choice), assessed until the last of: 1. 3 years after randomization; 2. 31 Dec 2024 or; 3. Six months after the last SLT during that timespan.]
- Achievement of 20% reduction in IOP [Срок оценки: From randomization until the last of: 1. 3 years after randomization; 2. 31 Dec 2024 or; 3. Six months after the last SLT during that timespan.]
- Absolute IOP reduction for each SLT iteration [Срок оценки: 1-6 months after each SLT, as described above]
- Pain perioperatively: on a scale [Срок оценки: Immediately after treatment]
- Pain postoperatively: on a scale [Срок оценки: During the first month]
- Light sensitivity postoperatively: on a scale [Срок оценки: During the first month]
- Impairment of vision postoperatively: on a scale [Срок оценки: During the first month]
- Redness postoperatively: on a scale [Срок оценки: During the first month]
- Adverse events [Срок оценки: From randomization until the last of: 1. 3 years after randomization; 2. 31 Dec 2024 or; 3. Six months after the last SLT during that timespan. However, generally adverse events are anticipated to emerge in the first post-operative days or weeks.]
Критерии участия
Критерии включения
- Included in the OSLT trial
- Followed up without the need for other treatment escalation than repeat SLT
Критерии исключения
- Unable to participate in follow up due to health conditions, strength or physical location.
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Швеция · 2 центра
- Department of Ophthalmology, Skaraborg Hospital — Skövde
- Department of Ophthalmology, NU Hospital Group — Uddevalla
Идентификаторы
NCT: NCT05159960 · OSLT-R · 277612