Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection

Официальное название

Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) at Point-of-Care to Identify and Quantify Biomarkers of Non-Exudative Age-Related Macular Degeneration

Обзор

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.

Вмешательства

• Устройство Retina imaging device (MSI-120) and AI (DeepMSI AI)
  This 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.

Первичные конечные точки

• Assessment of equivalency in sensitivity and specificity of the DeepMSI AI system compared with experienced clinicians for detection of AMD biomarkers. [Срок оценки: through study completion, an average of 6 months]

Критерии участия

Inclusion Criteria: AMD subjects:

• 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

Healthy subjects:

• Subjects over 40 years of age have not been diagnosed with any type of AMD and prior imaging that shows no signs of AMD or other types of retinopathies.
• A minimum of light perception visual acuity is required to detect the fixation target during imaging.
• Two masked clinicians must confirm and categorize them into healthy eyes. -

Критерии исключения

• Assessed prior to any considerations of inclusion:

• 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).
• History or Current Evidence of other types of retinopathy other than neAMD, e.g. Acute Retinal artery or Vein Occlusion, Diabetic Retinopathy, Idiopathic Epiretinal membrane, Myopic Maculopathy, Hypertension Retinopathy etc.
• History of Vitrectomy or Scleral Buckling for any kind of Vitreoretinopathy, e.g. Retinal Detachment, Epiretinal Membrane, Proliferative Diabetic Retinopathy etc. that could distort imaging results.
• Inability to Maintain Fixation: Including patients with advanced nystagmus, severe amblyopia, or cognitive impairments (dementia) affecting fixation stability.
• Severe Dry Eye or Ocular Surface Disease: Conditions that may interfere with imaging quality or patient comfort during the procedure.
• Subjects with essential tremor (head and neck tremors or unstable fixation to prevent adequate imaging)
• Inability to understand and refusal to sign informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• Contact Lens & Vision — Woodbridge

Идентификаторы

NCT: NCT07446582 · MultiCentre CS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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