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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Assessment of equivalency in sensitivity and specificity of the DeepMSI AI system compared with experienced clinicians for detection of AMD biomarkers.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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. -
排除标准
- •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
研究组 & 干预措施
AMD eyes
Eyes with Drusen and/or GA
干预措施: Retina imaging device (MSI-120) and AI (DeepMSI AI) (Device)
Healthy eyes
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.
干预措施: Retina imaging device (MSI-120) and AI (DeepMSI AI) (Device)
结局指标
主要结局
Assessment of equivalency in sensitivity and specificity of the DeepMSI AI system compared with experienced clinicians for detection of AMD biomarkers.
时间窗: through study completion, an average of 6 months
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.
次要结局
未报告次要终点