Coherent Optical Detection of Middle Ear Disease
OCTII
Otitis Media Diagnosis and Treatment: Coherent Optical Detection of Middle Ear Disease
2 other identifiers
interventional
235
1 country
2
Brief Summary
The purpose of this project is to see if optical coherence tomography (OCT), a new technology acting as an ultrasound for the ear, facilitates accurately diagnosing acute otitis media (AOM) and otitis media with effusion (OME) in children. Clinical diagnoses made using solely otoscopy will be compared to those made with the addition of OCT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Longer than P75 for not_applicable
2 active sites
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
April 24, 2022
CompletedFirst Posted
Study publicly available on registry
April 29, 2022
CompletedStudy Start
First participant enrolled
May 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
January 21, 2026
January 1, 2026
4.9 years
April 24, 2022
January 20, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Children's Wisconsin Urgent Care Clinic Analysis (Standard-of-Care Diagnosis)
The investigators will look at the percentage of patients that receive the decision for antibiotic prescriptions using only a standard-of-care examination (otoscopy) (prior to addition of a research-only OCT device).
5 years
Children's Wisconsin Urgent Care Analysis (Research Device Diagnosis)
The investigators will look at the percentage of patients that receive the decision for antibiotic prescriptions after the addition of a research-only OCT device.
5 years
Children's Wisconsin ENT Clinic Analysis (Standard-of-Care Diagnosis)
The investigators will look at the percentage of patients that receive the decision for surgical intervention using only standard-of-care examinations (otoscopy, audiometry/tympanometry) (prior to addition of research-only OCT devices).
5 years
Children's Wisconsin ENT Clinic Analysis (Research Devices Diagnosis)
The investigators will look at the percentage of patients that receive the decision for surgical intervention after the addition of research-only OCT devices.
5 years
Study Arms (3)
Children's Wisconsin Urgent Care Clinics
EXPERIMENTALSubjects will receive a standard-of-care otoscopy examination, followed by a research-only examination using an OCT device (PCT).
Children's Wisconsin (Effusion in 0 or 1 ear)
NO INTERVENTIONSubjects will only receive a standard-of-care otoscopy examination.
Children's Wisconsin (Effusion in 2 ears)
EXPERIMENTALSubjects will receive standard-of-care ear and hearing examinations (otoscopy and audiometry/tympanometry), followed by research-only examinations using two OCT devices (UIUC OCT and PCT).
Interventions
Results from standard-of-care examinations will be compared to research-only examination(s) (OCT device(s)).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Children with craniofacial abnormalities
- Children with diagnosed immunologic abnormalities
- Children with congenital syndromic conditions
- Current open and functioning ear tubes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Children's Wisconsin ENT Clinic
Wauwatosa, Wisconsin, 53226, United States
Children's Wisconsin Urgent Care Clinics
Wauwatosa, Wisconsin, 53226, United States
Related Publications (1)
Kerschner JE, Daley RA Jr, Link R, Jones RM, Peterson KJ, Chun RH, Flanary VA, Gorelik M, Keppel KL, Maksimoski M, Malloy M, Martin TJ, McCormick ME, Robey TC, Ansari S, Matoska GM, Rupcich CA, Saunderson ML, Shay SG, Sulman C, Erbe C, Thompson JK, Khampang P, Yan K, Simpson PM, Ho A, Monroy GL, Spillman DR, Aksamitiene E, Boppart SA. Clinical trial assessing the use of optical coherence tomography in decision making for children presenting with acute otitis media. Int J Pediatr Otorhinolaryngol. 2026 Mar;202:112728. doi: 10.1016/j.ijporl.2026.112728. Epub 2026 Jan 14.
PMID: 41547297DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Kerschner, MD
Medical College of Wisconsin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 24, 2022
First Posted
April 29, 2022
Study Start
May 24, 2022
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
January 21, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share