The Correlation of the Checkup Vision Assessment System to Standard In Office Visual Assessment

BACKGROUND AND INTRODUCTION Neovascular Age - related Macular Degeneration (AMD) is the most common cause of vision loss in subjects over the age of 60. Today in the US over 15 million people live with some form of AMD, and approximately 1.6-1.75 million people have neovascular AMD associated with vision loss. Approximately 200,000 new cases are diagnosed in the US annually; worldwide, approximately 500,000 new cases are diagnosed each year. With the aging of the overall population, prevalence of all forms of AMD is expected to rise to as many as 42 million by 2030, and it is projected that as many as 8 million seniors are at risk for losing vision from AMD within the next 5 years. Economic analysis indicates that vision impairment and eye disease cost the US an estimated $68 billion annually in healthcare expenditures, reduced productivity, and diminished quality of life, with AMD itself having at least a $30 billion dollar negative impact on gross domestic product.

Diabetes is the leading cause of blindness among working-age adults in the United States. According to recent studies funded by the National Eye Institute, diabetic retinopathy, one of the most common and debilitating complications of diabetes, increased by 3.7 million new cases over the last decade. Approximately 7.7 million Americans are now affected by diabetic retinopathy. Even more alarming, the rate is projected to climb to 11 million by 2030. People with diabetes are also at greater risk for cataracts and glaucoma. But diabetic retinopathy (DR) is by far the most common sight-threatening condition among people with diabetes and is the leading cause of blindness in adults aged 20 to 74 years. Diabetic retinopathy has an enormous impact on national health care spending: Twenty-one percent of national medical expenditures for ophthalmic complications are attributable to diabetes.

The current standard of care for DR is to identify and treat the disease just before irreversible visual loss occurs. In practice, this means that accurate, early diagnosis of severe Non-Proliferative DR and/or Diabetic Macular Edema (DME) is needed to identify suitable candidates for Laser Photocoagulation, vitrectomy or Intra-vitreal Triamcinolone, as appropriate. Because DR is frequently asymptomatic, and any degree of DR is a risk factor for further progression, annual comprehensive eye exams are recommended for all individuals with diabetes.

Use of home - based smartphone visual acuity testing apps has the potential to diagnose and monitor the progression of DR at a very early stage of the disease and to monitor visual changes in macular degeneration. Additionally, The AREDS2-HOME study showed early detection of neovascular AMD resulted in better vision outcomes compared to standard monitoring of neovascular AMD. Identification of changes in vision would trigger further clinical attention and possible interventions. It is conceivable that this would ultimately reduce the economic burden of DR and AMD.

DigiSight's Checkup Vision Assessment System allows subjects to frequently check their vision in a rapid, quantitative and reproducible way, and transmit that information in a secure and organized fashion, enabling their physicians to optimize and administer treatment in a timely manner. We designed the CLEAR study to evaluate the agreement between Checkup Vision Assessment System and standard office based visual acuity tests. Because the Checkup test is a near vision test we are using the Lebensohn Near Card as the main comparator.