Endpoint Assessments by Areas of Focus

Wet Age-Related Macular Degeneration (nAMD)

  • CNV location, area, classification (OCT/OCTA/FA)
  • OCT layer segmentation using a proprietary machine-learning algorithm with human grader oversight
  • subretinal/intraretinal fluid, Pigment Epithelial Detachment (PED), EZ status, RPE status (OCT)
  • Presence of Epiretinal Membrane (ERM), RPE rip/tear (OCT)
  • Area of leakage (FA)
  • Macular hole (OCT)
  • Hemorrhage (peripapillary, vitreous)
  • Subretinal fibrosis
  • Area and location of blood
  • Macular atrophy presence, area, and distance to fovea, RPE atrophy

Dry AMD / iAMD

  • OCT layer segmentation using a proprietary machine-learning algorithm with human grader oversight
  • Photoreceptor loss, EZ loss area and attenuation
  • RPE integrity/geographic atrophy (OCT/FA/FAF/CF)
  • Drusen and drusen volume
  • IRF/SRF
  • iRORA, cRORA
  • Hyperreflective foci
  • Reticular pseudodrusen
  • Pigmentary changes

Diabetic Retinopathy (DR) / Diabetic Macular Edema (DME) / Proliferative Diabetic Retinopathy (PDR)

  • OCT layer segmentation using a proprietary machine-learning algorithm with human grader oversight
  • Macular edema, subretinal/intraretinal fluid, pigment epithelial detachment disorganization of retinal layers (DRIL), epiretinal membrane (ERM) vitreomacular traction, macular hole,
  • Diabetic Retinopathy Severity Score (DRSS), photocoagulation, hemorrhages/microaneurysms, hard exudate, IRMA, venous beading, vessel tortuosity
  • Fluorescein leakage
  • Capillary nonperfusion
  • New vessels on disc and new vessels elsewhere

Inherited Retinal Diseases (IRDs)

  • OCT layer segmentation using a proprietary machine-learning algorithm with human grader oversight
  • Retinal pigment epithelium defect, ELM defect and Ellipsoid Zone (EZ) loss measured quantitatively with OCT and FAF
  • DDAF/QDAF

Retinopathy of Prematurity (ROP)

  • OCT layer segmentation using a proprietary machine-learning algorithm with human grader oversight
  • ROP Stage and Extent
  • Fibrosis

Safety Endpoint

  • OCT layer segmentation using a proprietary machine-learning algorithm with human grader oversight
  • Morphologic changes from baseline
  • Endothelial Cell Counts
  • Pigmentary changes
  • Nerve fiber layer analysis

Anterior Segment / Cornea / Dry Eye Disease

  • Anterior segment OCT
  • Corneal thickness
  • IOL rotation and decentration
  • Hyperemia
  • Corneal fluorescein staining

Device / AI

  • Macular Edema, SRF, IRF
  • DRSS

Dry Eye Disease

  • Corneal fluorescein staining

Endothelial Cell Health

  • Endothelial Cell Counts
    • Cell Density
    • Coefficient of Variance
    • Hexagonality
    • Average cell area

Uveitis

  • OCT layer segmentation using a proprietary machine-learning algorithm with human grader oversight
  • SRF, IRF, ERM, vitreomacular tractions, macular hole
  • Optic disc hyperfluorescence, macular edema, retinal vascular staining, leakage, capillary leakage, nonperfusion, macular ischemia, new vessels on disc, new vessels elsewhere, retinal staining, subretinal fibrotic lesions
  • Active inflammatory chorioretinal lesion, inflammatory vascular lesion

Retinal Vein Occlusion (RVO)

  • OCT layer segmentation using a proprietary machine-learning algorithm with human grader oversight
  • Subretinal fluid
  • Intraretinal fluid
  • Macular edema, PVD, ERM, vitreomacular traction
  • Nonperfusion
  • Leakage
  • New vessels on disc, new vessels elsewhere
  • Collateral vessels on disc, elsewhere

Glaucoma

  • Zonal retinal nerve fiber layer thickness (OCT)
  • Inner retinal layer analysis
  • Cup to disc ratio
  • Visual fields
  • ERG

Visual Function

  • Microperimetry, Static Perimetry, Kinetic Perimetry
  • Pupillometry
  • Full Field Stimuli Test
  • Light/Dark Adaptation
  • ERG
  • VEP
  • Ocular Motor Instability
  • BCVA, LLVA, LCVA, near visual acuity
  • Berkeley Rudimentary Vision Test
  • FrACT
  • Pelli-Robson Contrast Sensitivity, Mars Contrast Sensitivity
  • MN Read
  • Radner Reading Assessment
  • MLMT

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