An interventional study of OCT Device(s) in Otitis Media, Otitis Media With Effusion and Otitis Media Acute, sponsored by Medical College of Wisconsin. Recruiting at 2 sites in United States. Open to participants aged 12 Months to 6 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Diagnostic
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.
Otitis media (OM) is the most common diagnosis in pediatric patients seen for illness in the United States, affects 90% of all children, and is the most common indication for antimicrobial therapy and surgery in young children. Despite many attempts to improve diagnosis, treatment, and prevention, OM continues its highly prevalent impact on children and substantial ongoing morbidity. OM continues as the most common cause of hearing loss in children and leads to speech, educational and other developmental delays. OM causes life-threatening complications and is expensive, resulting in over $5 billion annually in U.S. health care expenditures. Despite the prevalence and difficulties with OM, diagnostic accuracy to allow appropriate treatment is lacking, leading to misplaced resources in treating OM. This proposal builds on our central hypothesis that enhanced diagnostic tools, specifically, optical coherence tomography (OCT), will yield improved diagnosis and lead to reduced need for antibiotics to treat acute OM, reduced surgical interventions for chronic otitis media, and overall fewer complications and cost associated with this disease. In this proposal, the investigators will explore three specific aims. The first aim, part A, the investigators will perform a comparative assessment of middle ear pathology using otoscopy and OCT in pediatric patients that present to a primary care clinic with complaints of otalgia or OM, with the hypothesis that OCT added to standard otoscopy will improve diagnostic accuracy and reduce overall antibiotic prescriptions. In part B of this aim, a comparative assessment of middle ear pathology using otoscopy along with audiometry/tympanometry and OCT will be performed in pediatric patients that present to the pediatric otolaryngology clinic with a referral for chronic otitis media with effusion (OME), with the hypothesis that OCT added to standard otoscopy and audiometry/tympanometry will improve diagnostic accuracy and reduce overall need for surgery in patients with OME. In the second aim, using the OCT images captured in the previous aim, the investigators will develop image processing and machine learning algorithms for automated identification of effusions and biofilms in OCT image data to augment OM diagnosis for medical decision making. Finally, using the OCT images captured previously, along with our machine learning algorithms, the investigators will establish OCT B-mode and M-mode image-based features that predict the resolution or persistence of middle ear effusions over time. Collectively, this project will demonstrate how these advances in diagnostic tools and algorithms will improve diagnosis and provide added information for clinical decision making in the management of OM.
88 studies on the registry are indexed under Otitis Media with Effusion; 17 are open to participants now.
This study's planned enrollment of 235 is above the median of 80 across 61 interventional studies indexed under Otitis Media with Effusion.
Browse Otitis Media with Effusion studies →Medical College of Wisconsin is the lead sponsor of 548 studies on the registry; 122 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 57 (76%) have results posted.
Compared within Otitis Media with Effusion, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Otitis Media. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects will receive a standard-of-care otoscopy examination, followed by a research-only examination using an OCT device (PCT).
Diagnostic Test: OCT Device(s)
Subjects will only receive a standard-of-care otoscopy examination.
Subjects 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).
Diagnostic Test: OCT Device(s)
Results from standard-of-care examinations will be compared to research-only examination(s) (OCT device(s)).
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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 5 years
Plan to share: No
Started May 2022 (actual). Primary completion is estimated for Apr 2027, 59 months after the start.
Of 16 interventional studies with no phase under Otitis Media with Effusion, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 65. This study's planned 59 months is above that.
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