NCT06971588

Brief Summary

The goal of the study is to see if the use of music improves attention during visual field exams for pediatric glaucoma patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

May 6, 2025

Last Update Submit

May 4, 2026

Conditions

Keywords

PediatricGlaucomaMusicResearchOphthalmology

Outcome Measures

Primary Outcomes (4)

  • Number of False Positives On VFE

    This outcome measurement will be used to assess reliability by seeing how often the patients were responding to stimuli that weren't present during the VFE. Assessment will be done by the physician after completion of the VFE by patient which takes about 10 minutes.

    Baseline, Follow-up visit up to 4 weeks

  • Number of False Negatives On VFE

    This measurement is a reliability tool to see if the patient missed any stimuli during VFE. Assessment will be done by the physician after completion of the VFE by patient which takes about 10 minutes.

    Baseline, Follow-up visit up to 4 weeks

  • Number of Fixation Losses on VFE

    This will evaluate any gaze deviation by the patient during VFE as a marker of inattention and test reliability. Assessment will be done by the physician after completion of the VFE by patient which takes about 10 minutes.

    Baseline, Follow-up visit up to 4 weeks

  • Test Duration (minutes) On VFE

    This will evaluate the length of the test as a marker for inattention and reliability if patient takes longer to complete the exam in one group or the other. Assessment will be done by the physician after completion of the VFE by patient which takes about 10 minutes.

    Baseline, Follow-up visit up to 4 weeks

Study Arms (2)

Music Group (first)

EXPERIMENTAL

This arm will involve the use of music during their initial VFE, and then they will take part in the non-music group during their second visit.

Other: Music intervention

Non-Music Group (first)

EXPERIMENTAL

This arm will involve the completion of the VFE with no music first, and then they will crossover and complete the arm involving the use of music during the visual field exam.

Other: Music intervention

Interventions

The intervention will involve patient-chosen music.

Music Group (first)Non-Music Group (first)

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Glaucoma or glaucoma suspect

You may not qualify if:

  • Post operative patient
  • Non English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilmer Eye Institute

Bethesda, Maryland, 20817, United States

Location

Related Publications (2)

  • Muralidharan S, Ichhpujani P, Bhartiya S, Singh RB. Eye-tunes: role of music in ophthalmology and vision sciences. Ther Adv Ophthalmol. 2021 Sep 2;13:25158414211040890. doi: 10.1177/25158414211040890. eCollection 2021 Jan-Dec.

    PMID: 34497975BACKGROUND
  • Blood AJ, Zatorre RJ. Intensely pleasurable responses to music correlate with activity in brain regions implicated in reward and emotion. Proc Natl Acad Sci U S A. 2001 Sep 25;98(20):11818-23. doi: 10.1073/pnas.191355898.

    PMID: 11573015BACKGROUND

Related Links

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Courtney Kraus, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: The study will involve the child being randomized to a control and experimental group, and about 2 weeks after the initial test, they will be asked to come in and take part in the alternate study group. During the control visit, the child will take the visual field exam as they would in their routine care.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 14, 2025

Study Start

June 1, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

May 5, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations