Clinical trial assessing the use of optical coherence tomography in decision making for children presenting with acute otitis media.

OBJECTIVE

To identify the ability of optical coherence tomography (OCT) to assist in the diagnosis and treatment of patients presenting to a primary care provider with signs and symptoms suggesting acute otitis media (AOM).

DESIGN-SETTING-

PARTICIPANTS

An NIH-funded clinical trial was conducted and enrolled 75 children between 1 and under 7 years of age. Children presented with complaints of ear pain or suspected ear infection from their caregiver history to primary care clinics associated with an academic children's hospital. These patients upon presentation were eligible to enroll in the trial. Following a complete history and physical exam, including pneumatic otoscopy (PO), patients were provided with a diagnosis and treatment plan. Diagnoses included: AOM, middle ear effusion without AOM, or no evidence of otitis media with a clear middle ear space. Following this, OCT was performed, and the diagnosis and treatment plan was reassessed using this data.

RESULTS

The diagnosis and/or treatment plan changed for 15.3 % of patients following the use of OCT compared with the initial use of PO. The greatest influence was seen in the patient group with MEE without AOM, with 36 % (5/14) of these patients having their diagnosis and/or treatment plan changed after OCT was employed.

CONCLUSIONS

OCT provides an additional adjunct for primary care providers to enhance visualization of the tympanic membrane and middle ear space. This data, in our clinical trial, resulted in enhanced clinical decision making, in particular for patients with MEE who were not diagnosed with AOM on PO.

TRIAL REGISTRATION INFORMATION: Coherent Optical Detection of Middle Ear Disease (OCTII).

CLINICALTRIALS: gov ID number: NCT05353569.