Diabetic Retinopathy Clinical Trial
Official title:
The Correlation of the Checkup Vision Assessment System to Standard In Office Visual Assessment
The CLEAR study is testing the level of agreement between visual acuity and Amsler grid testing using a mobile vision testing application, Checkup Study, and standard in office methods. In addition the percent of patients able to successfully complete home testing on the digital device will be assessed.
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.
CLEAR STUDY OBJECTIVES:
- Evaluate the agreement of the Checkup Vision Assessment System (Checkup) with the
reference device for assessing near visual acuity
- Evaluate the agreement of the Checkup Vision Assessment System (Checkup) with the
reference device for assessing metamorphopsia .
OVERVIEW The CLEAR study is a prospective, single arm evaluation of the Paxos Checkup app
tests, to be conducted in two phases under a common protocol. In the first phase the
comparative performance of Checkup to the pre-specified reference methods in assessing near
vision and in the presence of normal, AMD or DR was documented in 27 enrolled subjects.
Results of the first phase were used to finalize the protocol and estimated sample size for
Phase 2. There will be no formal statistical tests of Phase 1 results, and data from Phase 1
will not be pooled with Phase 2 results. The study will transition from Phase 1 to Phase 2
when it is believed that sufficient data have been collected in Phase 1 to plan and implement
Phase 2 (pivotal). Phase 2 is planned to enroll 110 patients, based on evaluation of Phase I
(pilot) results.
Subjects will be enrolled into three subpopulations based on eye health status: subjects with
AMD (approximately 50% of total), subjects with DR (approximately 30% of total), and subjects
with normal eye health (approximately 20% of total).
In Phase 2 the hypotheses associated with the two primary endpoints for the study will be
statistically tested against pre-specified performance goals. These performance goals are
based on the test-retest correlation of findings from the reference test methods in the study
population.
Primary Endpoint 1:
Corrected Near Visual Acuity (CNVA) assessed with the Checkup System will be compared to the
reference method CNVA (Lebensohn Near Card) in replicated measurements at each of two
in-office visits.
Primary Endpoint 2:
The Amsler Grid assessment with the Checkup will be compared to the reference method Amsler
Grid in replicated measurements at each of two in-office visits.
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