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

Gaize

Status: Enrolling

Conditions: Bipolar Disorder (BPD); Anxiety Disorder Generalized; Depression Disorders; Mood Disorders; ADHD

Treatments: Drug: Prescription Psychotropic Medications

Study type: Observational

Funder types: Industry

Identifiers

NCT07389473

24-GPHPV-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

50 participants in 2 patient groups

Experimental Group

Description:

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.

Treatment:

Drug: Prescription Psychotropic Medications

Control Group

Description:

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.

Treatment:

Drug: Prescription Psychotropic Medications