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| Name | Class |
|---|---|
| Welch Allyn | INDUSTRY |
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The purpose of this research study is to look at retinal abnormalities in outpatient renal dialysis patients using the FDA approved RetinaVue 100 hand-held (non-mydriatic) camera.
There are no studies evaluating (diabetic or non-diabetic) retinopathy in the renal dialysis patient population (~300,000 Americans). Approximately 50% of this population has End-stage Retinal Disease (ESRD) due to diabetes. Dialysis patients are among the most debilitated patients, and thus, have even more barriers to receiving their recommended annual retinal evaluation. The advent of the RetinaVue hand-held retinal camera holds great promise in this population, as dialysis patients access medical care 3 times a week, for several hours at a time at their dialysis clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RetinaVue 100 camera | Other | Participants will have a retinal screening completed by study staff using the FDA-approved RetinaVue 100 hand-held camera |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RetinaVue 100 camera | Device | Images of the subject's eye will be obtained using the RetinaVue 100 camera and uploaded to a secure network. The study doctor, a board-certified ophthalmologist, will interpret the patient images and return a diagnosis and management plan to the dialysis unit. |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of the RetinaVue Hand-Held 100 Camera | Usability of RetinaVue camera assessed by determining the number and percentage of inadequate images and the number and percentage of adequate images. | baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Retinopathy in a Dialysis Population | Number of participants found to have retinopathy in a dialysis population | Post retinal eye exam |
| Participant Satisfaction | Participant satisfaction survey data to be collected following the completion of retinal eye exam. Participants will be assessed on participant satisfaction measures such as comfort of experience, recovery time, and time invested in undergoing procedure vs. traditional retinal exam methods. The survey utilized a five-point Likert scale with the following responses: (1) strongly agree, (2) agree, (3) neutral, (4) disagree, (5) strongly disagree. The outcome measure is reported percentages for each of the six survey components. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seema Garg, MD, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Ophthalmology | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | RetinaVue 100 Camera | Participants will have a retinal exam completed by study staff using the FDA-approved RetinaVue 100 hand-held camera RetinaVue 100 camera: Images of the subject's retina will be obtained using the RetinaVue 100 camera and uploaded to a secure network. The study doctor, a board-certified ophthalmologist, will interpret the patient images and return a diagnosis and management plan to the dialysis unit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RetinaVue 100 Camera | All participants will have a retinal eye exam completed by study staff using the FDA-approved RetinaVue 100 hand-held camera |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | This measure is divided into categories by referral status, which is used as a proxy for retinal disease severity. With "no retinopathy" as the least severe or no disease and "retinopathy with referral" as the most severe. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Usability of the RetinaVue Hand-Held 100 Camera | Usability of RetinaVue camera assessed by determining the number and percentage of inadequate images and the number and percentage of adequate images. | Posted | Count of Units | Retinal Images | baseline visit | Retinal Images | Retinal Images |
|
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The duration of the eye exam and the period following, up to a two hour interval.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ESRD | This study only had only one arm. All those individuals who met eligibility criteria and provided voluntary consent, were enrolled to this study and followed the same procedures. |
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Limitations included small sample size which led to low power.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seema Garg, MD, PhD | University of North Carolina at Chapel Hill | 919-966-5296 | sgarg@med.unc.edu, ashton.madison@alumni.duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 16, 2016 | Jun 14, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D005128 | Eye Diseases |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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|
| Post retinal eye exam |
| Pre-and Post-eye Exam Rates in the Diabetic Dialysis Population | Changes in eye exam rates of the diabetic subset of total population from baseline (i.e. study entry) and post-enrollment in study. Baseline data were to be obtained from the UNC electronic medical record (EMR) as the number of participants with eye exams within the past year and post data would consist of the number of participants completing a study exam. | Baseline and post retinal eye exam |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | This measure is divided into categories by referral status, which is used as a proxy for retinal disease severity. With "no retinopathy" as the least severe or no disease and "retinopathy with referral" as the most severe. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | This measure is divided into categories by referral status, which is used as a proxy for retinal disease severity. With "no retinopathy" as the least severe or no disease and "retinopathy with referral" as the most severe. | Count of Participants | Participants |
|
| End-Stage Renal Disease Etiology | This measure is divided into categories by referral status, which is used as a proxy for retinal disease severity. With "no retinopathy" as the least severe or no disease and "retinopathy with referral" as the most severe. | Count of Participants | Participants |
|
| Diabetic dialysis population | Proportion of entire study population with a diabetes mellitus (DM) diagnosis. | Count of Participants | Participants |
|
| Retinal Images |
|
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| Secondary | Overall Retinopathy in a Dialysis Population | Number of participants found to have retinopathy in a dialysis population | Posted | Count of Participants | Participants | Post retinal eye exam |
|
|
|
| Secondary | Participant Satisfaction | Participant satisfaction survey data to be collected following the completion of retinal eye exam. Participants will be assessed on participant satisfaction measures such as comfort of experience, recovery time, and time invested in undergoing procedure vs. traditional retinal exam methods. The survey utilized a five-point Likert scale with the following responses: (1) strongly agree, (2) agree, (3) neutral, (4) disagree, (5) strongly disagree. The outcome measure is reported percentages for each of the six survey components. | This analysis is based on responses from the 39 that completed the survey. | Posted | Number | Percentage of participants | Post retinal eye exam |
|
|
|
| Secondary | Pre-and Post-eye Exam Rates in the Diabetic Dialysis Population | Changes in eye exam rates of the diabetic subset of total population from baseline (i.e. study entry) and post-enrollment in study. Baseline data were to be obtained from the UNC electronic medical record (EMR) as the number of participants with eye exams within the past year and post data would consist of the number of participants completing a study exam. | Baseline retinal examination data were not present within the EMR; therefore, this analysis could not be performed. | Posted | Baseline and post retinal eye exam |
|
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| Post-Hoc | Number of Diabetic Dialysis Subjects Undergoing Retinal Exam During Study Using the RetinaVue 100 Camera | Diabetic dialysis participants | Posted | Count of Participants | Participants | Up to as much as one year after study enrollment |
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| 0 |
| 68 |
| 0 |
| 68 |
| 0 |
| 68 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012164 | Retinal Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| Title | Measurements |
|---|---|
|
| Satisfied time complete eye exam:Disagree |
|
| Satisfied time complete eye exam:Strongly Disagree |
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| Comfort during eye exam : Strongly agree |
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| Comfort during eye exam : Agree |
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| Comfort during eye exam : Neutral |
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| Comfort during eye exam : Disagree |
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| Comfort during eye exam : Strongly Disagree |
|
| Comfort after eye exam : Strongly agree |
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| Comfort after eye exam : Agree |
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| Comfort after eye exam : Neutral |
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| Comfort after eye exam : Disagree |
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| Comfort after eye exam : Strongly Disagree |
|
| 1st eye quick recovery:Strongly agree |
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| 1st eye quick recovery:Agree |
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| 1st eye quick recovery:Neutral |
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| 1st eye quick recovery:Disagree |
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| 1st eye quick recovery:Strongly Disagree |
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| 2nd eye quick recovery:Strongly agree |
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| 2nd eye quick recovery:Agree |
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| 2nd eye quick recovery:Neutral |
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| 2nd eye quick recovery :Disagree |
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| 2nd eye quick recovery:Strongly Disagree |
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| Satisfied w overall experience:Strongly agree |
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| Satisfied w overall experience:Agree |
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| Satisfied w overall experience:Neutral |
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| Satisfied w overall experience:Disagree |
|
| Satisfied w overall experience:Strongly Disagree |
|
| Title | Measurements |
|---|---|
|