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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Participants will be recruited through local participants. Local psychiatrists will be enlisted to inform eligible patients about the research. Psychiatrists will disseminate information via study flyers displayed in their offices and through direct conversation with patients during appointments. This approach ensures informed and voluntary participation from individuals familiar with the psychiatric medication regimen, aligning with ethical research practices and privacy regulations. Potential participants' eligibility will be assessed based on predefined inclusion and exclusion criteria. If individuals meet these criteria and express interest, they will be provided with information about the study's objectives, potential risks, and benefits. |
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| Control Group | We will recruit control group participants by posting up flyers to the general population through community bulletin boards, social media, and local community health centers. These participants will be matched to our patient group by age, sex, and other relevant demographic factors but will not be taking psychotropic medications. Interested individuals will undergo a screening process to ensure they meet the specific criteria for the control group. To maintain transparency and informed consent, all participants, both in the study and control groups, will receive consent forms. Those willing to participate will have the opportunity to review and sign these forms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prescription Psychotropic Medications | Drug | Currently using a psychiatric medication as prescribed by a healthcare professional for longer than 3 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Collection of Ophthalmic Data | Accuracy of the Gaize device in detecting eye-movement metrics consistent with prescribed psychotropic medication use, as determined by Drug Recognition Expert (DRE) testing protocols in a controlled virtual environment. | 1 Day |
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Inclusion Criteria:
Exclusion Criteria:
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Participant population is limited to the city of Philadelphia, PA
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Apurva Raje Research Coordinator / Principal Investigator, BA | Contact | 732-397-1795 | apurva.raje@gaize.ai | |
| Rob Kaufmann CTO | Contact | rob.kaufmann@gaize.ai |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaize | Recruiting | Philadelphia | Pennsylvania | 19130 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27107471 | Background | 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. | |
| 34407728 | Background | 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. |
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| 34349300 | Background | 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. |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D019964 | Mood Disorders |
| D000098647 | Generalized Anxiety Disorder |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001008 | Anxiety Disorders |
| D000068105 | Bipolar and Related Disorders |
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