CDE Detailed Report

Disease: Multiple Sclerosis
Sub-Domain: Imaging Diagnostics
CRF: Imaging OCT Analysis - Spectralis Report Analysis

Displaying 1 - 17 of 17
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C16209 Imaging retinal nerve fiber layer thickness in nasal quadrant measurement ImgRNFLThiNasQuadMeasr The retinal nerve fiber layer (RNFL) thickness of the nasal quadrant The retinal nerve fiber layer (RNFL) thickness of the nasal quadrant RNFL thickness of the nasal quadrant Numeric Values

Record result in microns (?). To be answered for OD and/or OS, as applicable.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Free-Form Entry

micrometer
C15360 Imaging retinal nerve fiber layer thickness in superior quadrant measurement ImgRNFLThSupQuadMeasr The retinal nerve fiber layer (RNFL) thickness of the superior quadrant The retinal nerve fiber layer (RNFL) thickness of the superior quadrant RNFL thickness of the superior quadrant Numeric Values

Record result in microns (?). To be answered for OD and/or OS, as applicable.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Free-Form Entry

micrometer
C15361 Imaging signal strength quality value ImgSignalStrgthQualVal Signal strength of the OCT scan, based on signal to noise ratio Signal strength of the OCT scan, based on signal to noise ratio Quality Numeric Values

Value should be between 1 - 40. To be answered for OD and/or OS, as applicable.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Free-Form Entry

1 40
C15365 Imaging retinal nerve fiber layer thickness in superior quadrant abnormal status ImgRNFLThSupQuaAbnrmlStatus Whether the average retinal nerve fiber layer (RNFL) thickness of the superior quadrant of the eye is thin compared to the rest of the population Whether the average retinal nerve fiber layer (RNFL) thickness of the superior quadrant of the eye is thin compared to the rest of the population Was average RNFL thickness of the superior quadrant abnormal 0;1;2;9 Macula is of normal volume (green on the report);Macular volume is abnormally low, in the 5th percentile (yellow on the report);macular volume is abnormally low, in the 1st percentile (red on the report);Macular volume is abnormally great, in the 95th percentile (pale yellow on the report) Numeric values

Choose only one. To be answered for OD and/or OS, as applicable.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15369 Imaging retinal nerve fiber layer thickness in nasal quadrant abnormal status ImgRNFLThNasQuaAbnrmlStatus This variable signifies whether the average retinal nerve fiber layer (RNFL) thickness of the nasal quadrant of the eye is thin compared to the rest of the population This variable signifies whether the average retinal nerve fiber layer (RNFL) thickness of the nasal quadrant of the eye is thin compared to the rest of the population Was average RNFL thickness of the nasal quadrant abnormal 0;1;2;9 Macula is of normal volume (green on the report);Macular volume is abnormally low, in the 5th percentile (yellow on the report);macular volume is abnormally low, in the 1st percentile (red on the report);Macular volume is abnormally great, in the 95th percentile (pale yellow on the report) Numeric values

Choose only one. To be answered for OD and/or OS, as applicable.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15373 Imaging retinal nerve fiber layer thickness in inferior quadrant abnormal status ImgRNFLThInfQuaAbnrmlStatus This variable signifies whether the average retinal nerve fiber layer (RNFL) thickness of the inferior quadrant of the eye is thin compared to the rest of the population This variable signifies whether the average retinal nerve fiber layer (RNFL) thickness of the inferior quadrant of the eye is thin compared to the rest of the population Was average RNFL thickness of the inferior quadrant abnormal 0;1;2;9 Macula is of normal volume (green on the report);Macular volume is abnormally low, in the 5th percentile (yellow on the report);macular volume is abnormally low, in the 1st percentile (red on the report);Macular volume is abnormally great, in the 95th percentile (pale yellow on the report) Numeric values

To be answered for OD and/or OS, as applicable. Choose only one.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15318 Imaging follow-up scan indicator ImgFllwupScnInd Indicates if scan is a follow-up Indicates if scan is a follow-up Is this a follow-up scan Yes;No Yes;No Alphanumeric

Choose one

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15374 Imaging retinal nerve fiber layer thickness in inferior quadrant measurement ImgRNFLThickInfrQuadMeas The retinal nerve fiber layer (RNFL) thickness of the inferior quadrant The retinal nerve fiber layer (RNFL) thickness of the inferior quadrant RNFL thickness of the inferior quadrant Numeric Values

Record result in microns (?). To be answered for OD and/or OS, as applicable.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Free-Form Entry

micrometer
C15325 Imaging reference scan date ImgRefrnceScnDate The date and time (if applicable) that a reference scan was performed Date and time reference scan was performed Indicate date of reference scan Date or Date & Time

Only answer this question if "Yes" was answered for "Is this a follow-up scan?" Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Free-Form Entry

C15377 Imaging retinal nerve fiber layer thickness in temporal quadrant measurement ImgRNFLThTempQuaMeasr The retinal nerve fiber layer (RNFL) thickness of the temporal quadrant The retinal nerve fiber layer (RNFL) thickness of the temporal quadrant RNFL thickness of the temporal quadrant Numeric Values

Record result in microns (?). To be answered for OD and/or OS, as applicable.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Free-Form Entry

micrometer
C15332 Optical coherence tomography retinal nerve fiber layer thickness laterality type OCTRFNLThicknsLtrltyTyp The side of the eyes examined during retinal nerve fiber layer (RNFL) thickness analysis by optical coherence tomography (OCT) The side of the eyes examined during RNFL thickness analysis Laterality Type OD;OS right eye;left eye Alphanumeric

No additional instructions

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15380 Imaging retinal nerve fiber layer thickness in temporal quadrant abnormal status ImgRNFLThiTemQuadAbnrmlStatus This variable signifies whether the average retinal nerve fiber layer (RNFL) thickness of the temporal quadrant of the eye is thin compared to the rest of the population This variable signifies whether the average retinal nerve fiber layer (RNFL) thickness of the temporal quadrant of the eye is thin compared to the rest of the population Was average RNFL thickness of the temporal quadrant abnormal 0;1;2;9 Macula is of normal volume (green on the report);Macular volume is abnormally low, in the 5th percentile (yellow on the report);macular volume is abnormally low, in the 1st percentile (red on the report);Macular volume is abnormally great, in the 95th percentile (pale yellow on the report) Numeric values

Choose only one. To be answered for OD and/or OS, as applicable.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15333 Optical coherence tomography (OCT) oculus dexter (OD) macula volume measurement OCTODMaculaVolMeas Total macula volume of the right eye Total macula volume of the right eye Macula volume (OD) Numeric Values

Record in cubic millimeters (mm3) using 2 decimal places.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Free-Form Entry

cubic millimeter
C15385 Imaging retinal nerve fiber layer average overall thickness measurement ImgRNFLAvOvThMeasr Average overall retinal nerve fiber layer (RNFL) thickness (value is in the center of the circle on the report, marked "G") Average overall RNFL thickness (value is in the center of the circle on the report, marked "G") Average overall RNFL thickness (value in the center of the circle on report, marked "G") Numeric Values

Record result in microns (?). To be answered for OD and/or OS, as applicable.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Free-Form Entry

C15341 Optical coherence tomography (OCT) oculus sinister (OS) macula volume measurement OCTOSmclvolmeas Total macula volume of the left eye Total macula volume of the left eye Macula volume (OS) Numeric Values

Record in cubic millimeters (mm3) using 2 decimal places.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Free-Form Entry

cubic millimeter
C15388 Imaging retinal nerve fiber layer average overall thickness abnormal status ImgRNFLAvgOvrThickAbnrmlStatus This variable signifies whether the average retinal nerve fiber layer (RNFL) thickness of the eye is thin compared to the rest of the population This variable signifies whether the average retinal nerve fiber layer (RNFL) thickness of the eye is thin compared to the rest of the population Was average RNFL thickness thin compared to the rest of the population 0;1;2;9 RNFL thickness is within normal limits (p>0.05) (green on the report);RNFL is borderline below (p<0.05) (yellow on the report);RNFL below normal limits (p<0.01) (red on the report);RNFL is borderline above (p<0.05) (blue on the report) Numeric values

Choose only one. To be answered for OD and/or OS, as applicable.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15354 Optical coherence tomography (OCT) assisted reproduction technology (ART) mean value OCTARTMeanVal The number of B-scan images (frames) averaged assisted reproduction technology (ART). The number of B-scan images (frames) averaged assisted reproduction technology (ART). OCT ART Mean Numeric Values

Value should be between 1 - 100. To be answered for OD and/or OS, as applicable.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging OCT Analysis - Spectralis Report Analysis Imaging Diagnostics Assessments and Examinations

Free-Form Entry

1 100
CSV