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Recruiting NCT02157025

NCT02157025 A More Engaging Visual Field Test to Increase Use and Reliability in Pediatrics

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Clinical Trial Summary
NCT ID NCT02157025
Status Recruiting
Phase
Sponsor Nova Southeastern University
Condition Glaucoma, Suspect
Study Type INTERVENTIONAL
Enrollment 20 participants
Start Date 2015-02
Primary Completion 2027-04

Eligibility & Interventions

Sex All sexes
Min Age 5 Years
Max Age 8 Years
Study Type INTERVENTIONAL
Interventions
Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetryUsual Care procedures during Humphrey perimetry for children

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 20 participants in total. It began in 2015-02 with a primary completion date of 2027-04.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The majority of young children do not think that visual field (VF) testing of peripheral vision is similar to a game; therefore, it is not surprising that they have difficulty maintaining attention during VF testing and thus the test reliability suffers as a consequence. Poor VF reliability has been a longstanding, major issue since it leads to an increased number of tests and/or longer duration of time needed to determine when there are true vision losses. Providers are less likely to obtain VF tests in children since the results are of doubtful value and challenging to interpret when they are inconsistent. Effectively this means that children with untreated, slowly progressive eye diseases may go undiagnosed and incur greater visual losses. The investigators aim to create a prototype device that the investigators hypothesize will make VF testing more engaging for young children, thus increasing their attention and consistency of their responses to the test stimuli, which in turn should improve VF reliability. The components include a microdisplay video screen (1.5" diameter) as the fixation target (instead of the standard LED light) displaying video clips of popular cartoon characters, and audio clips of impersonated cartoon character voices presented by the test operator to provide instructional feedback based on the child's performance during testing. Improved VF reliability from the investigators intervention would translate to improved diagnosis and care for young childrens' peripheral vision loss through widespread implementation of the investigators innovative, affordable and readily adoptable system at eye care providers' offices.

Eligibility Criteria

Inclusion Criteria: * Ages 5-8 * Seen previously in the clinics at Nova Southeastern University's The Eye Care Institute with a diagnosis for glaucoma suspect or optic nerve abnormalities * Able and willing to complete VF testing at 2 study visits about a week apart * Provide informed consent Exclusion Criteria: * History of having previously completed a VF test using Humphrey static perimetry * Inability to understand study or communicate responses (cognitive impairment) * Unable to understand, read and speak English fluently

Contact & Investigator

Central Contact

So Yeon Lee, OD

✉ slee@nova.edu

📞 954-262-1478

Principal Investigator

Ava Bittner

STUDY DIRECTOR

University of California, Los Angeles

Frequently Asked Questions

Who can join the NCT02157025 clinical trial?

This trial is open to participants of all sexes, aged 5 Years or older, up to 8 Years, studying Glaucoma, Suspect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT02157025 currently recruiting?

Yes, NCT02157025 is actively recruiting participants. Contact the research team at slee@nova.edu for enrollment information.

Where is the NCT02157025 trial being conducted?

This trial is being conducted at Fort Lauderdale, United States.

Who is sponsoring the NCT02157025 clinical trial?

NCT02157025 is sponsored by Nova Southeastern University. The principal investigator is Ava Bittner at University of California, Los Angeles. The trial plans to enroll 20 participants.

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