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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| University of Southern California | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Retinal Disease | |||
| Retinal Disease |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 Month |
| 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. | 1 Month |
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Inclusion Criteria:
Exclusion Criteria:
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Twenty-four subjects, 12 without retinal disease (Cohort 1) and 12 with retinal disease (Cohort 2) will be recruited. Any subjects that do not comply with or complete the study protocol will be replaced to ensure that a total of 24 subjects complete the protocol. Subjects will be screened and recruited based on the Inclusion/Exclusion criteria outlined within this protocol. Subjects fulfilling the stated criteria and who are willing to comply must sign an informed consent prior form to study participation.
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| Name | Affiliation | Role |
|---|---|---|
| Quan Nguyen | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Group of Florida | Fort Lauderdale | Florida | 33334 | United States | ||
| Johns Hopkins Unversity |
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Recruitment Dates - 10/5/2012 to 11/5/2012. 3 Ophthalmic Clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Retinal Disease | |
| FG001 | Retinal Disease |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baltimore |
| Maryland |
| 21287 |
| United States |
| Valley Retina Institute | McAllen | Texas | 78503 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | No Retinal Disease | |
| BG001 | Retinal Disease | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | 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. | Posted | Mean | Standard Deviation | decibels | 1 Month |
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| 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. | Posted | Mean | Standard Deviation | decibels | 1 Month |
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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 | No Retinal Disease | 0 | 16 | 0 | 16 | |||
| EG001 | Retinal Disease | 0 | 16 | 0 | 16 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Quan Nguyen, MD Director of the Stanley M. Truhlsen Eye Institute | Stanley M. Truhlsen Eye Institute | 402-559-4276 | quan.nguyen@unmc.edu |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057092 | Geographic Atrophy |
| D003930 | Diabetic Retinopathy |
| D008269 | Macular Edema |
| D012170 | Retinal Vein Occlusion |
| D056833 | Central Serous Chorioretinopathy |
| D019773 | Epiretinal Membrane |
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
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| Title | Measurements |
|---|---|
|
| 51-64 years |
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| 65 years or great |
|
| Male |
|
|