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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new technology called optical coherence tomography (OCT) to improve diagnosing ear infections in children. OCT functions like an ultrasound for the ear, allowing doctors to see more details inside. The study compares traditional ear exams with and without the OCT device. Children who have experienced ear pain or infections and can speak English might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to advancing diagnostic technology for ear infections.

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 prior data suggests that this OCT device is safe for diagnosing ear infections in children?

Research has shown that optical coherence tomography (OCT) for ear imaging is generally safe. OCT is a non-invasive technology, meaning it doesn't enter the body. It functions like an ultrasound but uses light instead of sound waves. Studies have demonstrated that OCT can capture detailed images of the ear without causing harm.

While researchers continue to explore OCT for diagnosing ear infections, it is important to note that it doesn't involve surgery or medication. This results in lower risks compared to treatments involving drugs or physical procedures.

In summary, OCT offers a promising and safe method for examining the ear. Researchers are still studying its effectiveness in diagnosing ear infections in children, but the safety data so far is encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OCT device for ear infections because it offers a new way to examine the ear with high precision. Unlike traditional otoscopy, which relies on visual inspection, the OCT device uses light waves to create detailed images of the ear's internal structures, potentially identifying issues that are harder to see with the naked eye. This technique could lead to earlier and more accurate diagnosis of ear infections, improving treatment outcomes. By enhancing the clarity and detail of ear examinations, the OCT device might significantly advance how ear infections are diagnosed in children, reducing the need for repeated visits and unnecessary treatments.

What evidence suggests that the OCT device is effective for diagnosing ear infections?

Research has shown that the optical coherence tomography (OCT) device effectively diagnoses ear infections. In this trial, participants in the experimental arms will receive examinations using the OCT device alongside standard-of-care methods. One study found that using OCT reduced unnecessary antibiotic prescriptions by half compared to regular methods. Another study showed that the OCT otoscope was 90.6% accurate in detecting fluid in the middle ear in children. This technology functions like an ultrasound for the ear, providing clear images to aid doctors in making better diagnoses. Overall, these findings suggest OCT could enhance the identification and treatment of ear infections. ^{3 6 7 8 9}

Who Is on the Research Team?

Joseph Kerschner, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40267635/

Clinical utility of an optical coherence tomography middle ... Our results demonstrate that the OCT intervention reduced the odds of antibiotic prescribing by 50 % compared to the SOC.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165587625001430

Clinical utility of an optical coherence tomography middle ... Our results demonstrate that the OCT intervention reduced the odds of antibiotic prescribing by 50% compared to the SOC.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4330490/

Optical Coherence Tomography for the Diagnosis and ... We report the application of optical coherence tomography (OCT) to the diagnosis and evaluation of otitis media (OM).

4. withpower.com withpower.com/trial/oct-device-for-ear-infection-6314d

OCT Device for Ear Infection (OCTII Trial) The optical coherence tomography (OCT) otoscope demonstrated a high accuracy of 90.6% in detecting middle ear effusions (MEEs) among 45 pediatric patients, ...

5. nature.com nature.com/articles/s41746-019-0094-0

Automated classification platform for the identification of ... A flexible and comprehensive framework is presented that automatically extracts features from OCT images, classifies data, and presents clinically relevant ...

6. bcbsm.com bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/2090738.pdf

MEDICAL POLICY - OPTICAL COHERENCE ... Although the ClearView® device may be safe, noninvasive middle ear imaging using OCT presents some unique challenges for real-time, clinical use ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7248855/

Optical Identification of Middle Ear Infection - PMC We emphasize the utility of Raman spectroscopy as a prospective non-invasive technique for the identification of middle ear infection.

8. frontiersin.org frontiersin.org/journals/photonics/articles/10.3389/fphot.2022.929574/full

Multimodal Handheld Probe for Characterizing Otitis Media A combined benchtop Raman spectroscopy (RS) and optical coherence tomography (OCT) system was developed. Together, RS-OCT can non-invasively interrogate the ...

9. aetna.com aetna.com/cpb/medical/data/900_999/0928.html

Optical Coherence Tomography of the Head and Neck OCT offers a new approach for combined morphologic and functional measurements of the tympanic membrane and adjacent parts of the middle ear.