Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorAI-Spectral
About this trial
The goal of this observational clinical study is to learn if DeepMSI AI detects age-related macular degeneration (AMD) biomarkers with sensitivity and specificity equivalent to experienced clinicians in adults over 40 years old. The main questions it aims to answer are:
* Does DeepMSI AI detect AMD biomarkers with sensitivity equivalent to experienced clinicians? * Does DeepMSI AI detect AMD biomarkers with specificity equivalent to experienced clinicians? Participants' eyes will be imaged by MSI-120 and their images will be analyzed for AMD biomarkers by both DeepMSI AI and retina specialists independently.
Researchers will compare retina image analysis from DeepMSI AI with ground truth (clinicians' interpretations) to see if AI achieves equivalency in sensitivity and specificity.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects over 40 years of age diagnosed for ne AMD
Subject must be able to understand and must sign an IRB-approved ICF
Subject must have minimum of one prior visit to the clinic
Prior imaging must show signs of neAMD (e.g. drusen of different sizes and types with macular pigmentary changes, complete or incomplete retinal pigment epithelium and outer retinal atrophy) at least in one eye
Disqualifiers
Eyes with significant refractive media opacity (e.g. corneal opacity, significant cataract) that prevents adequate imaging
Severe Refractive Error: Extreme high myopia (≥ -10.00D) or hyperopia (≥ +6.00D) that may compromise image quality.
Unstable Ocular Conditions: Active ocular infections, severe uveitis, or status-post ocular trauma
Recent Intraocular Surgery: Patients who have undergone intraocular surgery (e.g., cataract, retinal, or glaucoma surgery) within the past 3 months (except for intravitreal injections for GA therapy).
Trial population
The study will enroll participants across the planned study sites including primary eye care and eye clinics in the USA. The study will include adults aged 40 years and older who have been previously imaged with retinal imaging instruments, meet all protocol-specified inclusion and exclusion criteria, and provide informed consent.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Retina imaging device (MSI-120) and AI (DeepMSI AI)
DeviceThis is single-arm intervention where device use (acquiring retina images with MSI-120 device and analyzing retinal images with the DeepMSI AI) is the primary intervention to assess performance. To eliminate any potential risk to patients, AI outputs from this study will not be disclosed to treating clinicians or participants during the study period.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: AMD eyes1 intervention
Group B: Healthy eyes1 intervention
Trial outcomes
Primary outcomes
1
Assessment of equivalency in sensitivity and specificity of the DeepMSI AI system compared with experienced clinicians for detection of AMD biomarkers.
Assessment of equivalency in sensitivity and specificity of the DeepMSI AI system compared with experienced clinicians for detection of AMD biomarkers (including drusen, GA) at the eye level as identified on MSI images, using the consensus of two masked retina experts as the reference standard.
Time frame
through study completion, an average of 6 monthsSponsors and contacts
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Source ClinicalTrials.gov