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Идёт набор NCT07548944

Observational Study to Investigate the Short-term Effects of Transcorneal Electrical Stimulation on Visual Performance

— Наблюдательное Retinitis Pigmentosa (RP) Usher Syndrome Cone Rod Dystrophy

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: Transcorneal Electrical Stimulation using the OkuStim System.
Кому может быть актуально
Состояния в реестре: Retinitis Pigmentosa (RP), Usher Syndrome, Cone Rod Dystrophy. 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
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Observational Study to Investigate the Short-term Effects of Transcorneal Electrical Stimulation (TES) on Visual Performance in Patients With Retinitis Pigmentosa and Similar Retinal Diseases

Обзор

Retinitis pigmentosa and similar degenerative diseases of the retina lead to progressive loss of vision. TES therapy with the CE-marked OkuStim® System is a treatment approved in the EU for slowing the progression of the disease. Patients increasingly report short-term subjective improvements in vision, which have not yet been systematically investigated. This exploratory study is conducted to determine whether these subjective short-term effects can be measured, and therefore also be quantified, by objective tests.

Подробное описание

This open-label observational study includes patients with retinitis pigmentosa or similar degenerative diseases (e.g. Usher syndrome, cone rod dystrophy) who already use the OkuStim System and are experiencing short-term effects following treatment.

Study procedure:

Participants will complete a questionnaire on previous experiences with short-term effects following transcorneal electrical stimulation therapy with the OkuStim System. If eligible, baseline ophthalmologic examinations will be performed, including slit-lamp examination, best-corrected visual acuity (BCVA), quick contrast sensitivity function (qCSF), kinetic perimetry, and microperimetry. Participants will then receive TES treatment with the OkuStim System according to the prescribed stimulation parameters for 30 minutes. Following treatment, examinations on BCVA and qCSF will be repeated. After a break of approx. 3.5 hours, participants will complete a second questionnaire assessing currently perceived changes in visual performance. Final examinations will be performed, including BCVA, qCSF, and microperimetry.

This scientific study aims to contribute to a better understanding of the underlying mechanisms of TES.

Вмешательства

  • Устройство Transcorneal Electrical Stimulation using the OkuStim System
    Single application of the OkuStim® System for TES therapy in accordance with its intended purpose for 30 minutes. No control or comparative intervention planned.

Первичные конечные точки

  • Best-corrected visual acuity [Срок оценки: - ETDRS: Baseline and approx. 3.5 hours after TES - Manifold Platform: Baseline, immediately after TES, and approx. 3.5 hours after TES]
  • Contrast sensitivity [Срок оценки: Baseline, immediately after TES, and approx. 3.5 hours after TES]
  • Retinal sensitivity [Срок оценки: Baseline and approx. 3.5 hours after TES]
  • Subjective changes in visual performance [Срок оценки: Approx. 3.5 hours after TES]

Критерии участия

Критерии включения

  • Adult patients (≥ 18 years) with clinically diagnosed retinitis pigmentosa (RP) or other similar degenerative retinal disease
  • Current treatment with TES using the OkuStim® System within the intended purpose
  • Subjective perception of short-term effects after TES treatment
  • Ability and willingness to give informed consent

Критерии исключения

  • Cognitive, psychological, or linguistic limitations that prevent informed consent or proper study participation
  • Presence of other eye diseases (e.g., cataract, glaucoma, macular degeneration) that, in the opinion of the investigator, compromise or confound study assessments
  • Simultaneous participation in other clinical studies that could influence the results of the study
  • Severe comorbidities that could compromise patient safety or study conduct

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Германия · 1 центр
  • Augenzentrum Frankfurt Prof. Koch GmbH — Frankfurt am Main

Идентификаторы

NCT: NCT07548944 · TES-STEP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗