1000 participants from up to 25 international locations who are at least 50 years old with either healthy eyes or a diagnosis of Age-Related Macular Degeneration (AMD) will be consented to provide images of their eyes for a new dataset. This dataset is an important step in developing an Artificial Intelligence (AI) based screening tool for AMD.
Age-related macular degeneration (AMD) is a leading cause of blindness in the world. The early and intermediate stages of AMD progress to late stage resulting in vision loss due to either geographic atrophy or neovascular AMD. Preventive measures to reduce treatment burden and prevent blindness are important. While there are no approved therapies for early disease, active research is underway. However, advancing therapeutic trials for AMD prevention remains challenging due to the lack of primary care involvement in early-stage AMD diagnosis. A clear need exists for a reliable screening tool, deployable in optometry or primary care facilities to identify those with an early stage of disease. While an Artificial Intelligence (AI) based screening tool would be an ideal solution, there are obstacles to its prospective validation due to difficulty in enrolling sufficient cases in a screening environment. A key step towards promoting this field lies in collecting a diverse dataset of multimodal imaging and providing a reference standard level 1 classification from a wide array of patients with AMD. Having such a benchmark dataset available for research purposes will empower the development and validation of AI models for AMD. This data can serve as the much-sought pathway to the rapid development of screening models, facilitating the referral of patients with the appropriate disease spectrum, and ultimately leading to the prevention of late AMD. This is a prospective, cross-sectional, multi-center, observational study to collect and develop a meticulously curated and diverse AMD benchmark dataset, featuring reference standard level 1 classification and comprehensive annotation of images. Study procedures include: * Patient history: demographics (age, sex, ethnicity, race), smoking history, family history of AMD * Physical exam: height and weight * Snellen best-corrected visual acuity (BCVA) * AMD classification (Beckman scale) Eligible participants will undergo one retinal imaging session of both eyes for the following: * Single field stereo color fundus photography (cFP) - pre and post dilation * Macular spectral domain-optical coherence tomography (SD-OCT) Due to the need for diversity in the dataset, sites need to represent a wide array of geographical locations. In addition, balancing will be done on enrolled participants with or without AMD including age, sex, and AMD level (worse eye selected as study eye).
Study Type
OBSERVATIONAL
Enrollment
1,000
Eligible participants will undergo one retinal imaging session of both eyes for the following: * Single field stereo color fundus photography (cFP) - pre and post dilation * Macular spectral domain-optical coherence tomography (SD-OCT)
Bergstrom Eye Research LLC
Fargo, North Dakota, United States
RECRUITINGErie Retina Research
Erie, Pennsylvania, United States
AMD Classification by Participant Count
A meticulously curated and diverse Benchmark dataset, featuring reference standard level 1 classification and annotated images for a wide range of AMD phenotypes is the primary outcome. Diversity of the dataset will in part be measured by classifying AMD status. The goal is to have: * 20% participants with no AMD * 30% participants with Early AMD * 30% participants with Intermediate AMD * 10% participants with Geographic Atrophy (GA) * 10% participants with Neovascular age-related macular degeneration (nAMD)
Time frame: up to 18 months
Geographic Location by Participant Count
A meticulously curated and diverse Benchmark dataset, featuring reference standard level 1 classification and annotated images for a wide range of AMD phenotypes is the primary outcome. Diversity of the dataset will in part be measured by geographic location. 1000 participants from up to 25 global sites will be included.
Time frame: up to 18 months
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Retina Foundation of the Southwest
Dallas, Texas, United States
NOT_YET_RECRUITINGValley Retina Institute
McAllen, Texas, United States
NOT_YET_RECRUITINGRetina Consultants of Texas (Houston)
The Woodlands, Texas, United States
NOT_YET_RECRUITINGUniversity of Utah - John A. Moran Eye Center
Salt Lake City, Utah, United States
NOT_YET_RECRUITINGUniversity Station Eye Care Clinic
Madison, Wisconsin, United States
RECRUITINGCharles Research Center
Buenos Aires, Argentina
NOT_YET_RECRUITINGAdelaide Eye and Retina Centre
Adelaide, Australia
NOT_YET_RECRUITINGCentre Hospialier Intercommunal de Paradis (Centre Monticelli Paradis)
Marseille, France
NOT_YET_RECRUITING...and 4 more locations