OCT Device for Ear Infection

(OCTII Trial)

Recruiting at 2 trial locations

Overseen By Christy Erbe

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Craniofacial abnormalities, Immunologic abnormalities, Congenital syndromic conditions, Ear tubes

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

235 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the OCT Device treatment for ear infections?

Research shows that OCT devices can effectively detect and differentiate middle ear effusions, which are common in ear infections. Additionally, OCT systems have been validated for use in primary care settings, demonstrating their utility in diagnosing conditions like ear infections. ^{1 2 3 4 5}

Is the OCT Device safe for use in humans?

Research on various OCT devices, including those used for ear conditions, suggests they are generally safe for human use. Studies have demonstrated the feasibility and safety of OCT systems in different applications, such as imaging the tympanic membrane and inner ear, without reporting significant safety concerns. ^{1 4 5 6 7}

How is the OCT Device treatment for ear infections different from other treatments?

The OCT Device for ear infections is unique because it uses optical coherence tomography to non-invasively and quantitatively assess middle ear conditions, providing detailed images and identifying bacterial biofilms, unlike traditional methods that rely on subjective visual cues. This device is portable and includes a machine learning platform for accurate diagnosis, making it a novel tool for managing ear infections. ^{1 4 5 8 9}

Research Team

Joseph Kerschner, MD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

This trial is for children with a parent-reported ear infection or pain, or those referred for otitis media with effusion evaluation at specific clinics. Participants must speak English. Children with current ear tubes, craniofacial abnormalities, immunologic or syndromic conditions, or effusion present for less than 8 weeks are excluded.

Inclusion Criteria

Referred for evaluation of otitis media with effusion at Children's Wisconsin ENT Clinic

Speak English

My child has had ear pain or an infection, as reported at a Children's Wisconsin Urgent Care Clinic.

Exclusion Criteria

My child has a craniofacial abnormality.

Children with other syndromic conditions

Current ear tubes

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Comparative Assessment

Comparative assessment of middle ear pathology using otoscopy and OCT in pediatric patients

5 years

Multiple visits as needed for assessments

Algorithm Development

Development of image processing and machine learning algorithms for automated identification of effusions and biofilms in OCT image data

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• OCT Device(s)

Trial Overview The study tests if optical coherence tomography (OCT), like an ultrasound for the ear, can accurately diagnose acute otitis media and otitis media with effusion in kids. It compares clinical diagnoses using OCT alongside traditional pneumatic otoscopy to those using only pneumatic otoscopy.

Participant Groups

Group I: Children's Wisconsin Urgent Care Clinics Experimental Treatment 1 Intervention

Subjects will receive a standard-of-care otoscopy examination, followed by a research-only examination using an OCT device (PCT).

Group II: Children's Wisconsin (Effusion in 2 ears) Experimental Treatment 1 Intervention

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).

Group III: Children's Wisconsin (Effusion in 0 or 1 ear) Active Control 1 Intervention

Subjects will only receive a standard-of-care otoscopy examination.

OCT Device(s) is already approved in United States, European Union for the following indications:

Approved in United States as OCT Device for:

• Acute otitis media (AOM)
• Otitis media with effusion (OME)

Approved in European Union as OCT Device for:

• Middle ear effusions
• Bacterial biofilms in the middle ear cavity

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University of Illinois at Urbana-Champaign

Collaborator

Trials

203

Recruited

40,600+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Findings from Research

The optical coherence tomography (OCT) otoscope demonstrated a high accuracy of 90.6% in detecting middle ear effusions (MEEs) among 45 pediatric patients, indicating its potential as a reliable diagnostic tool.

While the OCT otoscope was effective in detecting MEEs, it showed lower accuracy (70.8%) in differentiating between serous and nonserous MEEs, suggesting that while it is promising, further refinement may be needed for this specific application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Otitis Media Middle Ear Effusion Identification and Characterization Using an Optical Coherence Tomography Otoscope. Preciado, D., Nolan, RM., Joshi, R., et al.[2021]

A new low-cost and portable optical coherence tomography (OCT) system has been developed, weighing only 9 kg and costing around USD $8000, making it accessible for use in primary care centers and remote areas.

This system features innovative real-time mosaicking technology that allows for the creation of detailed cross-sectional images without the need for complex lateral scanning equipment, enhancing its utility for point-of-care diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economical and compact briefcase spectral-domain optical coherence tomography system for primary care and point-of-care applications. Dsouza, R., Won, J., Monroy, GL., et al.[2020]

The optical coherence tomograph (OCT) is a noninvasive device that provides high-resolution images of the retina, allowing for accurate evaluation of macular and chorioretinal conditions, as well as early detection of glaucoma.

OCT examinations are minimally uncomfortable for patients and are particularly useful for assessing macular pathologies and measuring retinal nerve fiber layer thickness to evaluate glaucomatous damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical coherence tomography. Ripandelli, G., Coppé, AM., Capaldo, A., et al.[2019]

The new endoscopic optical coherence tomography (OCT) system provides a wide field-of-view of 8 mm, allowing for detailed morphological and functional assessment of the tympanic membrane in the middle ear, which is crucial for diagnosing ear conditions.

This system enables three-dimensional visualization and precise measurement of tympanic membrane oscillation in response to sound, demonstrating its effectiveness in real-time imaging with minimal motion artifacts during in vivo applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic optical coherence tomography with wide field-of-view for the morphological and functional assessment of the human tympanic membrane. Kirsten, L., Schindler, M., Morgenstern, J., et al.[2020]

Endoscopic polarization-sensitive optical coherence tomography (PS-OCT) successfully visualized the collagen fiber layer of the tympanic membrane (TM) in a healthy volunteer, demonstrating its ability to differentiate between birefringent and nonbirefringent tissues.

The technique revealed distinct structural features of the TM, but challenges were noted in evaluating certain areas due to the TM's shape and thickness, indicating that further studies are needed to assess its diagnostic potential in both healthy and diseased ears.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo microstructural investigation of the human tympanic membrane by endoscopic polarization-sensitive optical coherence tomography. Steuer, S., Morgenstern, J., Kirsten, L., et al.[2023]

Cochlear implantation can now be performed in patients with some residual hearing, potentially enhancing their hearing experience by combining electrical and acoustic signals.

The study highlights the use of optical coherence tomography (OCT) as a novel imaging technique that allows for real-time visualization of inner ear structures, which could help surgeons preserve hearing during cochlear implantation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical coherence tomography imaging of the inner ear: a feasibility study with implications for cochlear implantation. Lin, J., Staecker, H., Jafri, MS.[2017]

The Hydra-OCT device, which uses dual wavelengths for retinal imaging, was successfully tested on 30 healthy participants, showing that it is feasible and safe with no adverse events reported.

Participants reported similar comfort levels with the Hydra-OCT compared to standard OCT machines, and there was no change in visual acuity, indicating that this new imaging method could provide valuable insights into retinal diseases without compromising patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of a Coaxial Dual-Wavelength Optical Coherence Tomography Apparatus. Cedro, L., Hasler, PW., Meier, C., et al.[2021]

A new handheld optical coherence tomography (OCT) system can non-invasively assess middle ear infections by detecting effusions and bacterial biofilms, improving upon traditional subjective diagnostic methods.

The integration of a real-time machine learning classifier allows for consistent and accurate categorization of middle ear conditions, making the OCT system more user-friendly and effective for diagnosing infections in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Handheld Briefcase Optical Coherence Tomography with Real-Time Machine Learning Classifier for Middle Ear Infections. Won, J., Monroy, GL., Dsouza, RI., et al.[2021]

Optical coherence tomography (OCT) has successfully transitioned from research to widespread clinical use in eye care, but its high cost and complexity limit access, especially in underserved populations.

Advancements in OCT technology, including improved speed, image quality, and functional capabilities like OCT angiography, are essential for making this diagnostic tool more portable and accessible for point-of-care use and telemedicine, potentially benefiting billions of people worldwide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical coherence tomography in the 2020s-outside the eye clinic. Chopra, R., Wagner, SK., Keane, PA.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Otitis Media Middle Ear Effusion Identification and Characterization Using an Optical Coherence Tomography Otoscope. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Economical and compact briefcase spectral-domain optical coherence tomography system for primary care and point-of-care applications. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Optical coherence tomography. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Endoscopic optical coherence tomography with wide field-of-view for the morphological and functional assessment of the human tympanic membrane. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

In vivo microstructural investigation of the human tympanic membrane by endoscopic polarization-sensitive optical coherence tomography. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Optical coherence tomography imaging of the inner ear: a feasibility study with implications for cochlear implantation. [2017]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of a Coaxial Dual-Wavelength Optical Coherence Tomography Apparatus. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Handheld Briefcase Optical Coherence Tomography with Real-Time Machine Learning Classifier for Middle Ear Infections. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Optical coherence tomography in the 2020s-outside the eye clinic. [2021]