Rapid, Non-invasive, Regional Functional Imaging of the Retina. (Diabetic Retinopathy Diagnosis Device)
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Diabetes |
| Therapuetic Areas: | Endocrinology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/17/2018 |
| Start Date: | February 2007 |
| End Date: | August 2015 |
Developing a Non-invasive Method and Device for Assessing the Degree of Midperipheral Retinal Ischemia in Diabetic Retinopathy.
The basic objective of this project is to test a modification of existing technology for
monitoring the responses of the pupil to light as a method for detecting regional losses of
function of the retina. The "instrument" consists of a commercially available set of goggles
that monitor the eye positions and pupils using infrared light and small cameras. The signals
from the monitoring cameras are collected in a computer that records how their pupils have
responded to each lighting condition. Because diabetics develop damage initially to certain
parts of the retina before they have more serious damage, the ultimate goal of this research
is to develop a simple, noninvasive, rapid method for widespread screening of diabetics in
order to identify those who may require medical attention and/or therapy for diabetic
retinopathy.
monitoring the responses of the pupil to light as a method for detecting regional losses of
function of the retina. The "instrument" consists of a commercially available set of goggles
that monitor the eye positions and pupils using infrared light and small cameras. The signals
from the monitoring cameras are collected in a computer that records how their pupils have
responded to each lighting condition. Because diabetics develop damage initially to certain
parts of the retina before they have more serious damage, the ultimate goal of this research
is to develop a simple, noninvasive, rapid method for widespread screening of diabetics in
order to identify those who may require medical attention and/or therapy for diabetic
retinopathy.
This study consists of three parts. The first part is to work with a limited number of normal
individuals and those with known diabetic retinopathy to test a variety of the light
conditions to find those that appear to be optimal for detecting retinal damage. The second
part of this study, which is to test the instrument and these conditions with both normal
subjects and a series of diabetics with varying degrees of severity of diabetic retinopathy.
This part of the study is intended to determine how sensitive and specific the detection
method is over the full range of retinal damage that is observed in diabetics. The third part
of this study is to use the same instrument either with the same testing conditions as used
for the diabetics or with modifications based on the regional areas of the retina that are
damaged for other conditions, including (but not limited to) sickle cell retinopathy,
retinitis pigmentosa, vascular diseases of the retina.
The risks from this study are minimal. All of the portions of the study that are required for
the clinical assessment of the participant's retinal health are consistent with the standard
of care for their condition. For diabetics with no clinically evident retinal damage from
diabetes, they will receive a regular dilated eye exam and photographs to document the
appearance of their retina. For those with more severe diabetic changes, special retinal
photographs and fluorescein angiography (photographs taken in the presence of a dye that is
injected into an arm vein that allows one to study the detailed changes of the blood vessels
in the retina) will be done to more accurately assess the degree of diabetic damage.
The long-term objective of this application is to develop an imaging device for the early
detection, diagnosis and quantification of the degree of midperipheral retinal ischemia in
Diabetic Retinopathy (DR). Earlier diagnosis of DR could facilitate intervention at a stage
that may prevent or lessen permanent damage from the ravages of the disease, in turn,
improving patient quality of life and reducing lifetime treatment costs. DR is one of the
more debilitating potential outcomes of diabetes posing a major threat to the quality of life
of diabetics. Experts believe that DR is the leading cause of blindness in the industrialized
world in people between the ages of 25 and 74 years old.
The American Academy of Ophthalmology states that DR is the leading cause of blindness among
working Americans and currently affects nearly seven million people in the U.S. Early
detection can help treat DR and salvage about 90 percent of vision loss, but about one-third
of the diabetic population remains undiagnosed, translating into approximately 5.7 million
people in the U.S. Delay in the primary diagnosis of diabetes allows diabetic complications
to progress significantly before detection further increasing the risks associated with the
disease by making the treatment much more complicated. Diabetes management guidelines
advocate initiation of therapeutic intervention early in the prognosis of the disease.
Estimates of diabetics in the U.S. with DR range from 15% to as high as 40%.
individuals and those with known diabetic retinopathy to test a variety of the light
conditions to find those that appear to be optimal for detecting retinal damage. The second
part of this study, which is to test the instrument and these conditions with both normal
subjects and a series of diabetics with varying degrees of severity of diabetic retinopathy.
This part of the study is intended to determine how sensitive and specific the detection
method is over the full range of retinal damage that is observed in diabetics. The third part
of this study is to use the same instrument either with the same testing conditions as used
for the diabetics or with modifications based on the regional areas of the retina that are
damaged for other conditions, including (but not limited to) sickle cell retinopathy,
retinitis pigmentosa, vascular diseases of the retina.
The risks from this study are minimal. All of the portions of the study that are required for
the clinical assessment of the participant's retinal health are consistent with the standard
of care for their condition. For diabetics with no clinically evident retinal damage from
diabetes, they will receive a regular dilated eye exam and photographs to document the
appearance of their retina. For those with more severe diabetic changes, special retinal
photographs and fluorescein angiography (photographs taken in the presence of a dye that is
injected into an arm vein that allows one to study the detailed changes of the blood vessels
in the retina) will be done to more accurately assess the degree of diabetic damage.
The long-term objective of this application is to develop an imaging device for the early
detection, diagnosis and quantification of the degree of midperipheral retinal ischemia in
Diabetic Retinopathy (DR). Earlier diagnosis of DR could facilitate intervention at a stage
that may prevent or lessen permanent damage from the ravages of the disease, in turn,
improving patient quality of life and reducing lifetime treatment costs. DR is one of the
more debilitating potential outcomes of diabetes posing a major threat to the quality of life
of diabetics. Experts believe that DR is the leading cause of blindness in the industrialized
world in people between the ages of 25 and 74 years old.
The American Academy of Ophthalmology states that DR is the leading cause of blindness among
working Americans and currently affects nearly seven million people in the U.S. Early
detection can help treat DR and salvage about 90 percent of vision loss, but about one-third
of the diabetic population remains undiagnosed, translating into approximately 5.7 million
people in the U.S. Delay in the primary diagnosis of diabetes allows diabetic complications
to progress significantly before detection further increasing the risks associated with the
disease by making the treatment much more complicated. Diabetes management guidelines
advocate initiation of therapeutic intervention early in the prognosis of the disease.
Estimates of diabetics in the U.S. with DR range from 15% to as high as 40%.
Inclusion Criteria:
- All subjects: must be greater than 18 years of age and capable of understanding
informed consent.
- All subjects must be willing to tolerate the placement of a set of goggles on their
face.
- All subjects must have visual acuities of 20/60 or better in at least one eye.
- Normal subjects must have a history of a normal eye examination within one year prior
to participation in this study.
- Normal subjects must have no history of ocular disease and no history of diabetes.
- Diabetic subjects must be diagnosed with diabetes upon prior clinical examination.
- Retinal Conditions subjects must be diagnosed with a retinal pathology, hereditary or
acquired.
Exclusion Criteria:
- Subjects with glaucoma and high myopia are specifically excluded.
- Diabetic subjects may not have had laser (panretinal photocoagulation) in both eyes.
We found this trial at
2
sites
Los Angeles, California 90095
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