DiabetesNCT01546766
Rapid, Non-invasive, Regional Functional Imaging of the Retina. (Diabetic Retinopathy Diagnosis Device)
An observational study of Diabetes and Retinal Disorders, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Retinal Disorders
- What is being tested?
- Pupillometry testing.
- Type of treatment
- Medical device
- How many people
- 315 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2007to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 145 normal adults 270 adults with diabetic retinopathy 50 adults with retinal conditions
Who may be able to join
- 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.
Who cannot join
- Subjects with glaucoma and high myopia are specifically excluded.
- Diabetic subjects may not have had laser (panretinal photocoagulation) in both eyes.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jules Stein Eye Institute, Dept. of Ophthalmology, David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Neuro Kinetics Inc.
Pittsburgh, Pennsylvania, 15238
About this study
Official title: 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.
Read the detailed description
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%.
- Conditions
- Diabetes, Retinal Disorders
- Being tested
- Pupillometry testing.
- Keywords
- Diabetes, Pupillary response, Retinal disorders, Midperipheral ischemia, Fundus photography, Optical coherence tomography
- Medical subject headings
- Diabetes Mellitus, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pupillometry testing.Device
| Study group | Role | What they receive |
|---|---|---|
| Subjects with diabetes | (Subjects that have been diagnosed with diabetes). Receives: Device: Pupillometry testing. | |
| Control volunteers | (Subjects with no history of ocular problems). Receives: Device: Pupillometry testing. | |
| Subjects with retinal conditions | (Subjects with a history of retinal disorders except diabetes). Receives: Device: Pupillometry testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupillary response
We will analyze the following three components of the pupillary response: latency, constriction velocity and amplitude. The measurements will be taken after initiation of the light stimulus.
These functions will be determined for each eye of each subject using both the central and annular stimuli. Each set of experimental conditions will yield a unique relative luminance ratio that can be used to compare the relative functional integrity of the peripheral retina with respect to the central macula.
Measured: 3 months
Secondary outcomes (1)
Pupillary response.
Constriction velocity, latency and amplitude will allow us to compare the sensitivity of the testing methods with a variety of diabetic cases so that we can establish the most appropriate method for generalized screening.
The secondary measures will include the differences in maximal constriction and the pupil diameters at the time of maximal rate of constriction as well as analyses of the impact of the light stimuli on the three latency measures of response.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startFeb 2007
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Neurolign, Jules Stein Eye Institute, National Eye Institute (NEI)
- Responsible party
- Principal investigator, Michael B. Gorin, University of California, Los Angeles
- Investigators
- Michael B. Gorin, MD, PhD, Principal investigator, Jules Stein Eye Institute, Dept. of Ophthalmology, David Geffen School of Medicine at UCLAAlexander Kiderman, PhD, Study director, Neuro Kinetics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546766
- Sponsor's protocol ID
- UCLA IRB#11-002987
- Other IDs
- 5R44EY018025-03
- Status last verified
- Nov 2023
- First submitted
- 1 Mar 2012
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Ortube MC, Kiderman A, Eydelman Y, Yu F, Aguilar N, Nusinowitz S, Gorin MB. Comparative regional pupillography as a noninvasive biosensor screening method for diabetic retinopathy. Invest Ophthalmol Vis Sci. 2013 Jan 2;54(1):9-18. doi: 10.1167/iovs.12-10241.
PubMed 23154459
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Non-invasive Method and Device for Assessing the Degree of Midperipheral Retinal Ischemia in Diabetic Retinopathy.
- ClinicalTrials.gov ID
- NCT01546766
- Acronym / sponsor ID
- UCLA IRB#11-002987
- Conditions
- Diabetes, Retinal Disorders
- Keywords
- Diabetes, Pupillary response, Retinal disorders, Midperipheral ischemia, Fundus photography, Optical coherence tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Neurolign, Jules Stein Eye Institute, National Eye Institute (NEI)
- Study start
- Feb 2007
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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%.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects with diabetes | – | Device: Pupillometry testing.(Subjects that have been diagnosed with diabetes). |
| Control volunteers | – | Device: Pupillometry testing.(Subjects with no history of ocular problems). |
| Subjects with retinal conditions | – | Device: Pupillometry testing.(Subjects with a history of retinal disorders except diabetes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 145 normal adults 270 adults with diabetic retinopathy 50 adults with retinal conditions
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- Subjects with glaucoma and high myopia are specifically excluded.
- Diabetic subjects may not have had laser (panretinal photocoagulation) in both eyes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pupillometry testing. | Device | Control volunteers, Subjects with diabetes, Subjects with retinal conditions |
Primary outcome
Pupillary response
Time frame: 3 months
We will analyze the following three components of the pupillary response: latency, constriction velocity and amplitude. The measurements will be taken after initiation of the light stimulus. These functions will be determined for each eye of each subject using both the central and annular stimuli. Each set of experimental conditions will yield a unique relative luminance ratio that can be used to compare the relative functional integrity of the peripheral retina with respect to the central macula.
1 secondary outcome
Pupillary response.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Results publication: PubMed 23154459Ortube MC, Kiderman A, Eydelman Y, Yu F, Aguilar N, Nusinowitz S, Gorin MB. Comparative regional pupillography as a noninvasive biosensor screening method for diabetic retinopathy. Invest Ophthalmol Vis Sci. 2013 Jan 2;54(1):9-18. doi: 10.1167/iovs.12-10241.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B. Gorin, MD, PhD principal investigator
Jules Stein Eye Institute, Dept. of Ophthalmology, David Geffen School of Medicine at UCLA
Alexander Kiderman, PhD study director
Neuro Kinetics, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Retinal Disorders, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupillary response (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01546766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.