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

NCT07389473 | Recruiting FDA Drug

• 1 other identifier: 24-GPHPV-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Drug: Prescription Psychotropic Medications

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.

Drug: Prescription Psychotropic Medications

Interventions

Prescription Psychotropic Medications DRUG

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

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participant population is limited to the city of Philadelphia, PA

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaize: lead

Study Sites (1)

Gaize

Philadelphia, Pennsylvania, 19130, United States

RECRUITING

Related Publications (3)

• 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 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.

  PMID: 34407728 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.

  PMID: 34349300 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Mood Disorders; Generalized Anxiety Disorder; Bipolar Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Anxiety Disorders; Bipolar and Related Disorders

Central Study Contacts

Apurva Raje Research Coordinator / Principal Investigator, BA

CONTACT

732-397-1795; apurva.raje@gaize.ai

Rob Kaufmann CTO

CONTACT

rob.kaufmann@gaize.ai

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: February 5, 2026
• Study Start: April 17, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)