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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07389473
Acronym
Rx Meds Gaize
Enrollment
50
Registered
2026-02-05
Start date
2024-04-17
Completion date
2028-08-01
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD, Anxiety Disorder Generalized, Bipolar Disorder (BPD), Depression Disorders, Mood Disorders

Brief summary

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.

Detailed 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.

Interventions

DRUGPrescription Psychotropic Medications

Currently using a psychiatric medication as prescribed by a healthcare professional for longer than 3 months.

Sponsors

Gaize
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Collection of Ophthalmic Data1 DayAccuracy 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.

Countries

United States

Contacts

CONTACTApurva Raje Research Coordinator / Principal Investigator, BA
apurva.raje@gaize.ai732-397-1795
CONTACTRob Kaufmann CTO
rob.kaufmann@gaize.ai

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026