Age-Related Macular Degeneration, Central Serous Retinopathy, Diabetic Retinopathy, Epiretinal Membrane, Geographic Atrophy, Macular Edema, Macular Hole, Pattern Dystrophy of Macula, Retinal Vein Occlusion
Conditions
Brief summary
To conduct a precision study to assess the microperimetry function of the Spectral OCT/SLO. The study will assess variability across measurements taken by three different operator-device configuration across clinical sites, variability between subjects within a given operator-device configuration, and variability within a subject for a single operator-device configuration.
Interventions
None listed
Sponsors
Johns Hopkins University
University of Southern California
Optos, PLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject must be 21 years of age or older. * Subjects recruited to Cohort 1 will have no known retinal disease except for refractive errors (-7.5 D to +7.5 diopters).Subjects who are recruited to Cohort 2 will have one or more of the following retinal pathologies: early and intermediate Age-Related Macular Degeneration, Geographic Atrophy, Diabetic Retinopathy (mild, moderate, severe), Macular Edema secondary to Diabetes, Retinal Vein Occlusion, Central Serous Retinopathy, Pattern Dystrophy, Epiretinal Membrane or Macular Hole. * Subjects who have signed an informed consent form. * Subjects who can comply with the protocol.
Exclusion criteria
* Subjects younger than 21 years of age. * Subjects who cannot comply with the protocol. * Subjects who cannot complete the Simple Test procedures * Subjects who are not available to be testing 3 times during the day (Morning, Mid - Day, and Afternoon). * Subjects with visual acuity worse than 20/100 (Best Corrected). * Subjects with dense media opacities. * Ocular surgery anticipated on the day of the study visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations | 1 Month | A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. For each subject, one eye was evaluated using 3 tests with repositioning at the start of each test. Test results were given in decibels which is the unit used in microperimetry testing. Overall mean and standard deviation in decibels were calculated for the two groups: normal and with pathology. |
| Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination. | 1 Month | A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. Test results were given in decibels as that is the standard measurement in microperimetry testing. For each subject, one eye was evaluated using 3 microperimetry tests with repositioning at the start of each test. Overall Repeatability SD and Repeatability SD Limit were calculated for the two groups: normal and with pathology. |
Countries
United States
Participant flow
Recruitment details
Recruitment Dates - 10/5/2012 to 11/5/2012. 3 Ophthalmic Clinics.
Participants by arm
| Arm | Count |
|---|---|
| No Retinal Disease | 12 |
| Retinal Disease | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Deviation | 1 | 1 |
| Overall Study | Study completed prior to site completion | 3 | 3 |
Baseline characteristics
| Characteristic | No Retinal Disease | Retinal Disease | Total |
|---|---|---|---|
| Age, Customized 21-35 years | 4 participants | 3 participants | 7 participants |
| Age, Customized 36-50 years | 4 participants | 3 participants | 7 participants |
| Age, Customized 51-64 years | 3 participants | 3 participants | 6 participants |
| Age, Customized 65 years or great | 1 participants | 3 participants | 4 participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination.
A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. Test results were given in decibels as that is the standard measurement in microperimetry testing. For each subject, one eye was evaluated using 3 microperimetry tests with repositioning at the start of each test. Overall Repeatability SD and Repeatability SD Limit were calculated for the two groups: normal and with pathology.
Time frame: 1 Month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Retinal Disease | Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination. | Repeatability SD | 16.16 decibels | Standard Deviation 0.531 |
| No Retinal Disease | Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination. | Repeatability SD Limit | 16.16 decibels | Standard Deviation 1.49 |
| Retinal Disease | Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination. | Repeatability SD | 12.23 decibels | Standard Deviation 0.682 |
| Retinal Disease | Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination. | Repeatability SD Limit | 12.23 decibels | Standard Deviation 1.91 |
Primary
Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations
A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. For each subject, one eye was evaluated using 3 tests with repositioning at the start of each test. Test results were given in decibels which is the unit used in microperimetry testing. Overall mean and standard deviation in decibels were calculated for the two groups: normal and with pathology.
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Retinal Disease | Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations | 16.16 decibels | Standard Deviation 1.735 |
| Retinal Disease | Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations | 12.23 decibels | Standard Deviation 3.508 |