Otitis MediaOCTIINCT05353569
Coherent Optical Detection of Middle Ear Disease
A study testing OCT Device(s) in people with Otitis Media and Otitis Media With Effusion, run by Medical College of Wisconsin at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 6 years
- Conditions the study is for
- Otitis Media, Otitis Media With Effusion, Otitis Media Acute
- What is being tested?
- OCT Device(s)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 May 2022to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Children with craniofacial abnormalities
- Children with diagnosed immunologic abnormalities
- Children with congenital syndromic conditions
- Current open and functioning ear tubes
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Children's Wisconsin ENT Clinic
Wauwatosa, Wisconsin, 53226
Katherine Peterson, MPH, 4148055356, kapeterson@mcw.edu
- Recruiting
Children's Wisconsin Urgent Care Clinics
Wauwatosa, Wisconsin, 53226
Katherine Peterson, MPH, 4148055356, kapeterson@mcw.edu
About this study
Official title: Otitis Media Diagnosis and Treatment: Coherent Optical Detection of Middle Ear Disease
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.
Read the detailed description
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.
- Conditions
- Otitis Media, Otitis Media With Effusion, Otitis Media Acute
- Being tested
- OCT Device(s)
- Medical subject headings
- Otitis Media, Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT Device(s)Diagnostic test
Results from standard-of-care examinations will be compared to research-only examination(s) (OCT device(s)).
| Study group | Role | What they receive |
|---|---|---|
| Children's Wisconsin Urgent Care Clinics | Experimental | Subjects will receive a standard-of-care otoscopy examination, followed by a research-only examination using an OCT device (PCT). Receives: Diagnostic Test: OCT Device(s) |
| Children's Wisconsin (Effusion in 0 or 1 ear) | No intervention | Subjects will only receive a standard-of-care otoscopy examination. |
| Children's Wisconsin (Effusion in 2 ears) | Experimental | 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). Receives: Diagnostic Test: OCT Device(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start24 May 2022
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign, National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Matthew Maksimoski, Medical College of Wisconsin
- Investigators
- Joseph Kerschner, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353569
- Sponsor's protocol ID
- 46057
- Other IDs
- 1R01DC019412-01A1
- Acronym
- OCTII
- Status last verified
- Jan 2026
- First submitted
- 24 Apr 2022
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41547297
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Otitis Media Diagnosis and Treatment: Coherent Optical Detection of Middle Ear Disease
- ClinicalTrials.gov ID
- NCT05353569
- Acronym / sponsor ID
- OCTII / 46057
- Conditions
- Otitis Media, Otitis Media With Effusion, Otitis Media Acute
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign, National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 24 May 2022 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children's Wisconsin Urgent Care Clinics | Experimental | Diagnostic Test: OCT Device(s)Subjects 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 intervention | –Subjects will only receive a standard-of-care otoscopy examination. |
| Children's Wisconsin (Effusion in 2 ears) | Experimental | Diagnostic Test: OCT Device(s)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). |
Who may qualify
- Ages
- 12 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Children with craniofacial abnormalities
- Children with diagnosed immunologic abnormalities
- Children with congenital syndromic conditions
- Current open and functioning ear tubes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT Device(s)Results from standard-of-care examinations will be compared to research-only examination(s) (OCT device(s)). | Diagnostic test | Children's Wisconsin (Effusion in 2 ears), Children's Wisconsin Urgent Care Clinics |
Primary outcome
Children's Wisconsin Urgent Care Clinic Analysis (Standard-of-Care Diagnosis)
Time frame: 5 years
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).
Children's Wisconsin Urgent Care Analysis (Research Device Diagnosis)
Time frame: 5 years
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.
Children's Wisconsin ENT Clinic Analysis (Standard-of-Care Diagnosis)
Time frame: 5 years
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).
Children's Wisconsin ENT Clinic Analysis (Research Devices Diagnosis)
Time frame: 5 years
The investigators will look at the percentage of patients that receive the decision for surgical intervention after the addition of research-only OCT devices.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Derived from this study: PubMed 41547297Kerschner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Kerschner, MD principal investigator
Medical College of Wisconsin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT Device(s) in people with Otitis Media and Otitis Media With Effusion, run by Medical College of Wisconsin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roxanne Link, APNP (414-266-3760, rlink@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Wisconsin Urgent Care Clinic Analysis (Standard-of-Care Diagnosis) (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05353569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.