Using optical technology to diagnose ear infections in children
Official title: Otitis Media Diagnosis and Treatment: Coherent Optical Detection of Middle Ear Disease
Run by Medical College of Wisconsin · NCT05353569 · Data updated 2026-11-12
This study is testing if a new eye-based technology can help doctors better diagnose ear infections in children compared to the usual methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Months to 6 Years |
| Sex | All |
| Enrollment | 235 (estimated) |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 2 sites (Wauwatosa, Wisconsin and 1 other locations) |
| Status | Recruiting |
| Started | May 24, 2022 |
| Main results expected | April 2027 |
| Study ends | April 2028 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT05353569 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include children presenting with complaints of ear infections or ear pain at designated clinics.
✕Probably not a fit
Patients with craniofacial abnormalities, immunologic disorders, congenital syndromic conditions, or those with current functioning ear tubes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to evaluate the effectiveness of optical coherence tomography (OCT) as a diagnostic tool for acute otitis media (AOM) and otitis media with effusion (OME) in pediatric patients. The study will compare traditional otoscopy diagnoses with those made using OCT to determine if the latter improves diagnostic accuracy. Given the high prevalence of otitis media in children and its associated complications, the research seeks to enhance diagnostic capabilities, potentially reducing unnecessary antibiotic use and surgical interventions. The study will be conducted in primary care and ENT clinics, focusing on children presenting with ear pain or infection complaints.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses and better management of ear infections in children, reducing complications and healthcare costs.
How similar studies have gone: While the use of OCT in this context is relatively novel, similar diagnostic advancements have shown promise in improving accuracy in other medical fields.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Parental complaint of ear infection or ear pain (Children's Wisconsin Urgent Care Clinics) OR referred for evaluation of otitis media with effusion (Children's Wisconsin ENT Clinic) * Speak English Exclusion Criteria: * Children with craniofacial abnormalities * Children with diagnosed immunologic abnormalities * Children with congenital syndromic conditions * Current open and functioning ear tubes
Where it's running
-
Children's Wisconsin ENT Clinic
Wauwatosa, Wisconsin, United States Recruiting -
Children's Wisconsin Urgent Care Clinics
Wauwatosa, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Joseph Kerschner, MD — Medical College of Wisconsin
- Study coordinator: Roxanne Link, APNP
- Email: rlink@mcw.edu
- Phone: 414-266-3760
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.