Diabetic Retinopathy, Eye Diseases, Kidney Failure, Chronic
Conditions
Keywords
retinal screening, outpatient dialysis
Brief summary
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.
Detailed description
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.
Interventions
DEVICERetinaVue 100 camera
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.
Sponsors
Welch Allyn
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject must currently be seeking treatment for end-stage renal disease (ESRD) at one of the specified dialysis clinics. * The subject must be ≥ 18 years of age.
Exclusion criteria
* The subject is \<18 years of age. * No exclusions will be made on the basis of gender, ethnicity, or race.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability of the RetinaVue Hand-Held 100 Camera | baseline visit | Usability of RetinaVue camera assessed by determining the number and percentage of inadequate images and the number and percentage of adequate images. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Retinopathy in a Dialysis Population | Post retinal eye exam | Number of participants found to have retinopathy in a dialysis population |
| Participant Satisfaction | Post retinal eye exam | 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. |
| Pre-and Post-eye Exam Rates in the Diabetic Dialysis Population | Baseline and post retinal eye exam | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RetinaVue 100 Camera All participants will have a retinal eye exam completed by study staff using the FDA-approved RetinaVue 100 hand-held camera | 68 |
| Total | 68 |
Baseline characteristics
| Characteristic | RetinaVue 100 Camera |
|---|---|
| Age, Customized No retinopathy | 54.7 years STANDARD_DEVIATION 18.1 |
| Age, Customized Retinopathy without referral | 60.0 years STANDARD_DEVIATION 6.6 |
| Age, Customized Retinopathy with referral | 57.1 years STANDARD_DEVIATION 11.6 |
| Diabetic dialysis population Diabetes: No | 31 Participants |
| Diabetic dialysis population Diabetes: Yes | 37 Participants |
| End-Stage Renal Disease Etiology Data Missing | 7 Participants |
| End-Stage Renal Disease Etiology Diabetes: No retinopathy | 7 Participants |
| End-Stage Renal Disease Etiology Diabetes: Retinopathy without referral | 8 Participants |
| End-Stage Renal Disease Etiology Diabetes: Retinopathy with referral | 13 Participants |
| End-Stage Renal Disease Etiology Hypertension: No retinopathy | 12 Participants |
| End-Stage Renal Disease Etiology Hypertension: Retinopathy without referral | 1 Participants |
| End-Stage Renal Disease Etiology Hypertension: Retinopathy with referral | 7 Participants |
| End-Stage Renal Disease Etiology Other: No retinopathy | 13 Participants |
| End-Stage Renal Disease Etiology Other: Retinopathy without referral | 2 Participants |
| End-Stage Renal Disease Etiology Other: Retinopathy with referral | 4 Participants |
| Race/Ethnicity, Customized African American: No retinopathy | 14 Participants |
| Race/Ethnicity, Customized African American: Retinopathy without referral | 6 Participants |
| Race/Ethnicity, Customized African American: Retinopathy with referral | 11 Participants |
| Race/Ethnicity, Customized Caucasian: No retinopathy | 11 Participants |
| Race/Ethnicity, Customized Caucasian: Retinopathy without referral | 3 Participants |
| Race/Ethnicity, Customized Caucasian: Retinopathy with referral | 8 Participants |
| Race/Ethnicity, Customized Data Missing | 1 Participants |
| Race/Ethnicity, Customized Hispanic: No retinopathy | 8 Participants |
| Race/Ethnicity, Customized Hispanic: Retinopathy without referral | 2 Participants |
| Race/Ethnicity, Customized Hispanic: Retinopathy with referral | 4 Participants |
| Sex/Gender, Customized Female : No retinopathy | 17 Participants |
| Sex/Gender, Customized Female : Retinopathy without referral | 6 Participants |
| Sex/Gender, Customized Female : Retinopathy with referral | 6 Participants |
| Sex/Gender, Customized Male : No retinopathy | 16 Participants |
| Sex/Gender, Customized Male : Retinopathy without referral | 5 Participants |
| Sex/Gender, Customized Male : Retinopathy with referral | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 68 |
| other Total, other adverse events | 0 / 68 |
| serious Total, serious adverse events | 0 / 68 |
Outcome results
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.
Time frame: baseline visit
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Images | Usability of the RetinaVue Hand-Held 100 Camera | Inadequate Images | 20 Retinal Images |
| Images | Usability of the RetinaVue Hand-Held 100 Camera | Adequate Images | 116 Retinal Images |
Secondary
Overall Retinopathy in a Dialysis Population
Number of participants found to have retinopathy in a dialysis population
Time frame: Post retinal eye exam
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Images | Overall Retinopathy in a Dialysis Population | No retinopathy | 33 Participants |
| Images | Overall Retinopathy in a Dialysis Population | Retinopathy | 35 Participants |
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.
Time frame: Post retinal eye exam
Population: This analysis is based on responses from the 39 that completed the survey.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Images | Participant Satisfaction | Satisfied time complete eye exam:Disagree | 0 Percentage of participants |
| Images | Participant Satisfaction | Satisfied time complete eye exam : Neutral | 10.3 Percentage of participants |
| Images | Participant Satisfaction | Satisfied time complete eye exam:Strongly agree | 61.5 Percentage of participants |
| Images | Participant Satisfaction | Satisfied time complete eye exam : Agree | 28.2 Percentage of participants |
| Images | Participant Satisfaction | Satisfied time complete eye exam:Strongly Disagree | 0 Percentage of participants |
| Images | Participant Satisfaction | Comfort during eye exam : Strongly agree | 75.4 Percentage of participants |
| Images | Participant Satisfaction | Comfort during eye exam : Agree | 24.6 Percentage of participants |
| Images | Participant Satisfaction | Comfort during eye exam : Neutral | 0 Percentage of participants |
| Images | Participant Satisfaction | Comfort during eye exam : Disagree | 0 Percentage of participants |
| Images | Participant Satisfaction | Comfort during eye exam : Strongly Disagree | 0 Percentage of participants |
| Images | Participant Satisfaction | Comfort after eye exam : Strongly agree | 82.0 Percentage of participants |
| Images | Participant Satisfaction | Comfort after eye exam : Agree | 18.0 Percentage of participants |
| Images | Participant Satisfaction | Comfort after eye exam : Neutral | 0 Percentage of participants |
| Images | Participant Satisfaction | Comfort after eye exam : Disagree | 0 Percentage of participants |
| Images | Participant Satisfaction | Comfort after eye exam : Strongly Disagree | 0 Percentage of participants |
| Images | Participant Satisfaction | 1st eye quick recovery:Strongly agree | 53.9 Percentage of participants |
| Images | Participant Satisfaction | 1st eye quick recovery:Agree | 41.0 Percentage of participants |
| Images | Participant Satisfaction | 1st eye quick recovery:Neutral | 5.1 Percentage of participants |
| Images | Participant Satisfaction | 1st eye quick recovery:Disagree | 0 Percentage of participants |
| Images | Participant Satisfaction | 1st eye quick recovery:Strongly Disagree | 0 Percentage of participants |
| Images | Participant Satisfaction | 2nd eye quick recovery:Strongly agree | 59.0 Percentage of participants |
| Images | Participant Satisfaction | 2nd eye quick recovery:Agree | 35.9 Percentage of participants |
| Images | Participant Satisfaction | 2nd eye quick recovery:Neutral | 5.1 Percentage of participants |
| Images | Participant Satisfaction | 2nd eye quick recovery :Disagree | 0 Percentage of participants |
| Images | Participant Satisfaction | 2nd eye quick recovery:Strongly Disagree | 0 Percentage of participants |
| Images | Participant Satisfaction | Satisfied w overall experience:Strongly agree | 79.5 Percentage of participants |
| Images | Participant Satisfaction | Satisfied w overall experience:Agree | 20.5 Percentage of participants |
| Images | Participant Satisfaction | Satisfied w overall experience:Neutral | 0 Percentage of participants |
| Images | Participant Satisfaction | Satisfied w overall experience:Disagree | 0 Percentage of participants |
| Images | Participant Satisfaction | Satisfied w overall experience:Strongly Disagree | 0 Percentage of participants |
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.
Time frame: Baseline and post retinal eye exam
Population: Baseline retinal examination data were not present within the EMR; therefore, this analysis could not be performed.
Post Hoc
Number of Diabetic Dialysis Subjects Undergoing Retinal Exam During Study Using the RetinaVue 100 Camera
Time frame: Up to as much as one year after study enrollment
Population: Diabetic dialysis participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Images | Number of Diabetic Dialysis Subjects Undergoing Retinal Exam During Study Using the RetinaVue 100 Camera | No retinopathy | 11 Participants |
| Images | Number of Diabetic Dialysis Subjects Undergoing Retinal Exam During Study Using the RetinaVue 100 Camera | Retinopathy without referral | 9 Participants |
| Images | Number of Diabetic Dialysis Subjects Undergoing Retinal Exam During Study Using the RetinaVue 100 Camera | Retinopathy with referral | 17 Participants |