Long-term psychotropic medication effects on eye movements measured with the Gaize VR headset
An Observational Study to Evaluate the Effects of Long-term Use of Psychotropic Medications on Eye Movement Patterns With the Gaize Device
This project will test whether the Gaize VR headset can detect eye-movement patterns associated with long-term use of prescribed psychotropic medications in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Gaize Industry-sponsored |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07389473 on ClinicalTrials.gov |
What this trial studies
This observational protocol uses the Gaize VR headset to record eye movements while applying Drug Recognition Expert (DRE) oculomotor tests in a controlled virtual environment. Adults aged 18–65 who have used prescribed psychiatric medications for more than three months and who have normal or corrected vision will be enrolled. Key exclusions include recent eye surgery or dilation, photosensitive epilepsy, clinical blindness, prosthetic eye, significant ocular diseases, or other medical conditions/medications that markedly affect cognition or motor function. Measured eye-movement parameters will be compared to established DRE signatures to determine whether the device can reliably identify medication-associated oculomotor changes.
Who should consider this trial
Good fit: Adults 18–65 who have been taking prescribed psychotropic medications for more than three months and have normal or corrected vision are the intended participants.
Not a fit: People with significant ocular disease, recent eye surgery or dilation, photosensitive epilepsy, prosthetic or missing eyes, or medical conditions/medications that substantially affect cognition or motor function are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide an objective, noninvasive way to monitor medication-related eye movement changes and help clinicians detect side effects earlier.
How similar studies have performed: Traditional DRE oculomotor tests have shown predictable eye-movement changes with various substances, but using a VR headset to detect long-term prescribed psychotropic medication effects is a novel and not well-established application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Philadelphia, Pennsylvania
- Gaize — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Apurva Raje Research Coordinator / Principal Investigator, BA
- Email: apurva.raje@gaize.ai
- Phone: 732-397-1795
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.