Engaging Visual Field Test for Pediatric Eye Examinations

Recruiting at1 trial location

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Nova Southeastern University

Disqualifiers: Previous VF test, Cognitive impairment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial aims to improve vision tests for young children by using a small screen with cartoon videos and voices. This approach helps keep children engaged, making the test results more reliable and aiding in better diagnosis and care for vision problems.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment involving cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry for pediatric eye examinations?

Research shows that using engaging visual tasks, like animated characters, can help children maintain focus and improve the quality of eye measurements. Children enjoyed these tasks, which led to better pupil responses, suggesting that similar engaging methods could be effective during Humphrey perimetry. ^{1 2 3 4 5}

How is the treatment using cartoon video and audio instructions during Humphrey perimetry different from other treatments for pediatric eye examinations?

This treatment is unique because it uses engaging cartoon videos and character voices to hold children's attention during eye tests, making the experience more enjoyable and potentially improving test accuracy compared to traditional methods that may not capture children's interest as effectively. ^{1 3 5 6 7}

Research Team

Eligibility Criteria

This trial is for children aged 5-8 who can complete vision tests and have been seen at Nova Southeastern University's The Eye Care Institute for possible glaucoma or optic nerve issues. They must understand English well and be able to communicate their responses.

Inclusion Criteria

Provide informed consent

I have been seen at Nova Southeastern University for possible glaucoma or optic nerve issues.

I can attend 2 study visits a week apart for vision field tests.

Exclusion Criteria

I can understand and communicate about the study.

Unable to understand, read and speak English fluently

You have completed a visual field test using Humphrey static perimetry before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo visual field testing using either the cartoon intervention or usual care procedures

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry (Behavioural Intervention)

Trial Overview The study is testing a new way to do vision tests using cartoon videos and character voices as instructions, hoping it will keep kids' attention better than the usual method. This could make the test results more reliable.

Participant Groups

Group I: Cartoon Intervention Experimental Treatment 1 Intervention

Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry

Group II: Usual Care Active Control 1 Intervention

Usual care procedures for Humphrey perimetry in young children

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

Dr. George L. Hanbury II

Nova Southeastern University

Chief Executive Officer since 2011

PhD in Higher Education Administration from Nova Southeastern University

Dr. Gary S. Margules

Nova Southeastern University

Chief Medical Officer since 2010

MD from University of Miami

Findings from Research

A new head-mounted VR display with gaze-contingent flicker pupil perimetry (VRgcFPP) was tested on 20 children aged 3-11 years, showing it effectively measures visual field responses while allowing children to move freely and engage with the task.

The fixation counting task was found to be the most effective method for eliciting strong pupil responses, as children enjoyed it the most, indicating it could be the best practice for assessing visual fields in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintaining fixation by children in a virtual reality version of pupil perimetry. Portengen, BL., Naber, M., Jansen, D., et al.[2023]

Patients who received audiovisual instructions via a video showed better performance and motivation during automated Humphrey visual field testing compared to those who received verbal instructions, with 85% of the video group finding the instructions helpful.

The video-instructed group had a higher reliability in test results (47.5%) and reported feeling more confident and less anxious, suggesting that audiovisual aids can enhance patient understanding and performance in medical testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effect of audiovisual and verbal instructions on patient performance while performing automated Humphrey visual field testing. Maheshwari, D., Nair, A., Tara, TD., et al.[2023]

The Olleyes VisuALL-K, a pediatric virtual reality perimetry device, demonstrated comparable threshold sensitivity to the traditional Humphrey Field Analyzer (HFA) in mapping peripheral vision in children, with mean sensitivities of 31.8 dB for VRP and 31.0 dB for HFA.

Despite a longer testing time of 7.6 minutes for VRP compared to 5.3 minutes for HFA, children reported higher satisfaction with the VRP, indicating its potential as a more engaging and flexible option for vision testing in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Virtual Reality Perimetry and Standard Automated Perimetry in Normal Children. Groth, SL., Linton, EF., Brown, EN., et al.[2023]

A gamified approach to assessing Contrast Sensitivity Function (CSF) in children with amblyopia was tested on 25 participants aged 4 to 9 years, showing that the method was engaging and easy for young children to understand and complete.

The new testing method effectively distinguished between varying degrees of amblyopia and was able to separate affected eyes from healthy ones, suggesting it could be a practical tool for pediatric vision assessments in various settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Psychophysics Be Fun? Exploring the Feasibility of a Gamified Contrast Sensitivity Function Measure in Amblyopic Children Aged 4-9 Years. Elfadaly, D., Abdelrazik, ST., Thomas, PBM., et al.[2020]

Automated static perimetry can be reliably performed in children aged 8 years and older, with good reproducibility in those aged 13 and above, indicating its feasibility in clinical settings.

Continuous light increment perimetry (CLIP) was found to be more effective than the fast threshold strategy (FT), showing fewer abnormal results and false positives, especially beneficial for younger children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and outcome of automated static perimetry in children using continuous light increment perimetry (CLIP) and fast threshold strategy. Wabbels, BK., Wilscher, S.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Maintaining fixation by children in a virtual reality version of pupil perimetry. [2023]

2. India pubmed.ncbi.nlm.nih.gov

Comparison of the effect of audiovisual and verbal instructions on patient performance while performing automated Humphrey visual field testing. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Development of a Pediatric Visual Field Test. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Virtual Reality Perimetry and Standard Automated Perimetry in Normal Children. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A novel paediatric game-based visual-fields assessor. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Can Psychophysics Be Fun? Exploring the Feasibility of a Gamified Contrast Sensitivity Function Measure in Amblyopic Children Aged 4-9 Years. [2020]

7. Denmark pubmed.ncbi.nlm.nih.gov

Feasibility and outcome of automated static perimetry in children using continuous light increment perimetry (CLIP) and fast threshold strategy. [2022]