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Идёт набор NCT07389473

Evaluate the Effects of Long-term Use of Psychotropic Medications on Eye Movement Patterns With the Gaize Device

— Наблюдательное ADHD Depression Disorders Mood Disorders Anxiety Disorder Generalized

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: Prescription Psychotropic Medications.
Кому может быть актуально
Состояния в реестре: ADHD, Depression Disorders, Mood Disorders, Anxiety Disorder Generalized. Базовые параметры: 18 лет — 65 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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Официальное название

An Observational Study to Evaluate the Effects of Long-term Use of Psychotropic Medications on Eye Movement Patterns With the Gaize Device

Обзор

The study aims to verify if the Gaize ocular device can effectively identify eye movements indicative of prescribed psychotropic medication usage by employing Drug Recognition Expert (DRE) testing protocols within a controlled virtual environment.

Подробное описание

The use of psychotropic (psychiatric) medications for various psychiatric disorders is a common practice. Long-term use of such medications necessitates monitoring due to potential side effects, including ophthalmic issues (1). The Gaize VR headset represents a novel approach to monitoring these effects by utilizing Drug Recognition Expert (DRE) testing methods to detect eye movements associated with substance use.

Psychotropic medications have been associated with a range of visual and oculomotor side effects, which can impact patient safety and quality of life (2). The prevalence of these effects in long-term users is not fully characterized in the literature, and traditional methods of assessment may miss subclinical alterations in eye movement or function. Eye movement patterns are altered predictably by the use of various substances, such as cannabis, alcohol, and other psychoactive drugs. DRE protocols utilize oculomotor tests to infer recent drug use (3). These protocols are, however, often subjective and require trained personnel to administer, leading to potential variability in assessment and risk of false positives. Advances in virtual reality technology have allowed for more precise and controlled assessment of eye movements. VR headsets can isolate and measure specific eye movement parameters, potentially providing a more accurate and objective measure of oculomotor function and impairment.

Вмешательства

  • Препарат Prescription Psychotropic Medications
    Currently using a psychiatric medication as prescribed by a healthcare professional for longer than 3 months.

Первичные конечные точки

  • Collection of Ophthalmic Data [Срок оценки: 1 Day]

Критерии участия

Критерии включения

  • Adults aged between 18 and 65, having given written informed consent to participate in the research trial.
  • Currently using a psychiatric medication as prescribed by a healthcare professional for longer than 3 months.
  • Normal or corrected to normal vision using either glasses or contact lenses, or surgery.

Критерии исключения

  • Enrolled in, or participated in another clinical trial within 30 days before the study
  • Having a prosthetic eye, missing eye, or wearer of an eye patch LASIK or other eye surgery within the prior 21 days.
  • Had your eyes dilated by a medical doctor in the previous 24 hours.
  • Photosensitive epilepsy
  • Diagnosed with clinical blindness
  • Medical Conditions: Participants with medical conditions or medications that could significantly affect cognitive and motor functions are excluded. Participants with conditions such as Glaucoma, macular degeneration, cataracts, lazy eye (amblyopia), or optic neuritis, or genetic anisocoria (unequal pupil size) will be excluded.
  • Current or past head inject/ traumatic brain injury (TBI)
  • Pregnancy: Pregnant individuals will be excluded from the study due to the potential risks associated with psychiatric medications.
  • History of Severe Motion Sickness: Participants with a history of severe motion sickness in VR environments may be excluded, as they may not tolerate the VR headset well.
  • Potential participants who are unable to provide consent for the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 1 центр
  • Gaize — Philadelphia

Публикации

  • Hartman RL, Richman JE, Hayes CE, Huestis MA. Drug Recognition Expert (DRE) examination characteristics of cannabis impairment. Accid Anal Prev. 2016 Jul;92:219-29. doi: 10.1016/j.aap.2016.04.012. Epub 2016 Apr 22. PMID 27107471
  • Williams R, Hui A. Common systemic medications that every optometrist should know. Clin Exp Optom. 2022 Mar;105(2):149-156. doi: 10.1080/08164622.2021.1945409. Epub 2021 Aug 18. PMID 34407728
  • Mahal P, Suthar N, Nebhinani N. Spotlight on Oculogyric Crisis: A Review. Indian J Psychol Med. 2021 Jan;43(1):5-9. doi: 10.1177/0253717620942096. Epub 2020 Sep 3. PMID 34349300

Идентификаторы

NCT: NCT07389473 · 24-GPHPV-01

Первоисточники (государственные реестры)

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