| TEMPLATE ID | Clinical image acquisition and validation OCT |
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| Concept | Clinical image acquisition and validation OCT |
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| Description | Register the acquisition and subsequent examination of ophthalmic tomography test. |
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| Purpose | Register the acquisition and subsequent examination of ophthalmic tomography test. |
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| References | |
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| Authors | name: Aitor Eguzkitza; organisation: Universidad Pública de Navarra - Complejo Hospitalario de Navarra; email: aitor.eguzkiza@unavarra.es; date: 2016-07-20 |
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| Other Details Language | name: Aitor Eguzkitza; organisation: Universidad Pública de Navarra - Complejo Hospitalario de Navarra; email: aitor.eguzkiza@unavarra.es; date: 2016-07-20 |
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| Other Details (Language Independent) | - MetaDataSet:Sample Set : Template metadata sample set
- Copyright: © openEHR Foundation
- Owner: Aitor Eguzkitza, aitor.eguzkiza@unavarra.es
- Speciality: Ophthalmology
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| Language used | en |
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| Citeable Identifier | 1013.26.117 |
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| Root archetype id | openEHR-EHR-SECTION.clinical_image_acquisition.v0 |
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| Clinical image acquisition and validation OCT | Clinical image acquisition and validation OCT: Manages the acquisition and validation of diagnostic tests based on medical imaging. |
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| Ophthalmic tomography examination | Ophthalmic tomography examination: Record of clinical findings using optical coherence tomography with ophthalmic purposes. |
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| Data | |
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| Any event | Any event: Default, unspecified point in time or interval event which may be explicitly defined in a template or at run-time. |
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| Data | |
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| Clinical description | Clinical description: A term, commonly coded, expressing an overall interpretation of the OCT test. |
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| Test result | Test result: Details of the ophthalmic tomography examination test result for each eye. |
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| Side | Side: Determines the eye on which the test was performed.Matches to DICOM Laterality (0020,0060) attribute.
Matches to DICOM Laterality (0020,0060) attribute.
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| Structure analyzed | Structure analyzed: The anatomic structure analyzed in this study.
Matches to DICOM Anatomic Region Sequence (0008,2218) attribute. Values permitted are defined by DICOM standard (PS 3.16) inside the table with Context ID 4211 (Ophthalmic OCT Anatomic Structure Imaged).
Value set: ac0001 |
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| Reference image | Reference image: Information about the image on which the position of OCT acquisitions/slices will be referenced. |
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| Acquisition method | Acquisition method: Ophthalmic photography acquisition method chosen to obtain the reference image.
Matches to DICOM Anatomic Region Sequence (0022,0015) attribute. Values permitted are defined by DICOM standard (PS 3.16) inside the table with Context ID 4202 (Ophthalmic Photography Acquisition Device).
Value set: ac0003 |
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| Image type | Image type: Identifies the fundus imaging modalities obtained from the acquisition of the reference image.
Corresponds to the value 4 of the DICOM image type attribute (0008,0008).
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| Comment | Comment: Narrative description of clinically relevant information identifiable on the reference image. |
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| Reference image | Reference image: Image on which the position of OCT acquisitions/slices will be referenced. |
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| Multiframe properties | Multiframe properties: Information about the slices of the retina obtained by OCT the test. |
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| Number of frames | Number of frames: Number of slices in the study (from 1 to n).
Matches to DICOM (0028,0008) attribute.
>=1 |
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| OCT slice analysis | OCT slice analysis: Analysis of OCT slices considered relevant in the study. |
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| Frame pointer | Frame pointer: Number identifying a frame among the rest in the study, to highlight its relevance on diagnosis.
Matches to DICOM (0028,0009) attribute.
>=1 |
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| OCT slice | OCT slice: Current slice of the retina regarding the image of reference. |
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| Comment | Comment: Narrative description of clinically relevant information identifiable on the specific frames selected from the acquisition. |
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| Reports | Reports: Information about image reports related to the current OCT study. |
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| Report type | Report type: Defines the purpose of the report built from data acquired on the OCT device.
- OCT overview
- Retina exam
- Retina change
- 3D view
- Thickness map exam
- Thickness map change
- RNFL thickness exam
- RNFL thickness change
- RNFL thickness trend
- Asymmetry analysis
- RNFL & asymmetry analysis
- Posterior pole assessment
- Other
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| Report content | Report content: Which kind of graphs are included in the report.
- Reference image
- Single OCT scan
- OCT volume scan
- Retinal thickness profile
- Retinal thickness map
- RNFL thickness profile
- RNFL thickness map
- Thickness profile change
- Thickness map change
- Periapillary RNFL thickness classification
- Retinal average thickness
- Asymmetry OD-OS
- Hemisphere asymmetry
- RNFL thickness trend
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| Comment | Comment: Narrative description of clinically relevant information identifiable on the current report. |
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| Report | Report: Report related to the current OCT study. |
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| Retinal thickness | Retinal thickness: Information related to retinal thickness measurement. |
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| Comment | Comment: Narrative description of clinically relevant information identifiable on the analysis of ophthalmic thickness measurements. |
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| Clinical findings | Clinical findings: Every finding considered clinically relevant, found on posterior chamber of the eye.
Value set: ac0002 |
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| State | |
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| Confounding factors | Confounding factors: Patient circumstances which may affect interpretation of the result. |
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| Intraocular pressure | Intraocular pressure: Value of intraocular pressure in mmHg.
Matches to DICOM (0022,000B) attribute.
0..90 mmHg (UCUM: mm[Hg]) |
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| Axial length of the eye | Axial length of the eye: Axial length of the eye in mm.
Matches to DICOM (0022,0030) attribute.
>=0 mm |
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| Horizontal field of view | Horizontal field of view: The horizontal field of view in degrees.
Matches to DICOM (0022,000C) attribute.
Units: ° (UCUM: deg) |
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| Contrast/Bolus | Contrast/Bolus: Information about the contrast agents administered prior to or during the acquisition.
Matches to DICOM (0018,0012) attribute. |
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| Contrast/bolus agent | Contrast/bolus agent: Identification of the contrast agent.
Matches to DICOM (0018,0012) attribute. Values permitted are defined by DICOM standard (PS 3.16) inside the table with Context ID 4200 (Ophthalmic Imaging Agent).
- Fluorescein
- Indocyanine green
- Rose Bengal
- Trypan blue
- Methylene blue
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| Contrast/bolus volume | Contrast/bolus volume: Volume injected in milliliters of diluted contrast agent.
Matches to DICOM (0018,1041) attribute.
>=0 ml |
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| Contrast/bolus volume ingredient concentration | Contrast/bolus volume ingredient concentration: Milligrams of active ingredient per milliliter of (diluted) agent.
Matches to DICOM (0018,1049) attribute.
>=0 mg/ml |
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| Protocol | |
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| Medical Device | Medical Device: An instrument, apparatus, implant, material or similar, used in the provision of healthcare. In this context, a medical device includes a broad range of devices which act through a variety of physical, mechanical, thermal or similar means but specifically excludes devices which act through medicinal means such as pharmacological, metabolic or immunological methods. The scope is inclusive of disposable devices as well as durable or persisting devices that require tracking, maintenance activities or regular calibration, recognising that each type of device has specific data recording requirements. |
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| Device name | Device name: Identification of the medical device, preferably by a common name, a formal fully descriptive name or, if required, by class or category of device.
This data element will capture the term, phrase or category used in clinical practice. For example: <brand name><machine> (XYZ Audiometer); <size> <brand name> <intravenous catheter> (14G Jelco IV catheter); or <brand name/type> <implant>. Coding with a terminology is desirable, where possible, although this may be local and depending on local supplies available.
Value set: terminology:Snomed?subset=Ophthalmic%20tomography%20acquisition%20device&language=en-GB |
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| Type | Type: The category or kind of device.
Not applicable if a category is already recorded in 'Device name'.
Example: if the 'Device' is named as a 'urinary catheter'; the 'Type' may be recorded as 'indwelling' or 'condom'.Coding with a terminology is desirable, where possible. This may include use of GTIN or EAN numbers. |
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| Description | Description: Narrative description of the medical device. |
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| Unique device identifier (UDI) | Unique device identifier (UDI): A numeric or alphanumeric string that is associated with this device within a given system.
Often fixed to the device as a barcode. |
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| Manufacturer | Manufacturer: Name of manufacturer. |
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| Date of manufacture | Date of manufacture: Date the device was manufactured. |
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| Serial number | Serial number: Number assigned by the manufacturer which can be found on the device, and should be specific to each device., its label, or accompanying packaging. |
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| Catalogue number | Catalogue number: The exact number assigned by the manufacturer, as it appears in the manufacturer's catalogue, device labeling, or accompanying packaging. |
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| Model number | Model number: The exact model number assigned by the manufacturer and found on the device label or accompanying packaging. |
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| Batch/Lot number | Batch/Lot number: The number assigned by the manufacturer which identifies a group of items manufactured at the same time, usually found on the label or packaging material. |
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| Software version | Software version: Identification of the version of software being used in the medical device.
When the medical device is an actual software application, record the version of the software using this data element. When the medical device has multiple software applications embedded within it, record each software component in a separate CLUSTER archetype within the Components SLOT - either as a nested instance of another CLUSTER.device archetype or using a CLUSTER archetype designed specifically for recording software details (but not yet available at time of this archetype development). |
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| Date of expiry | Date of expiry: Date after which the device/product is no longer fit for use, usually found on the device itself or printed on the accompanying packaging.
This date usually applies only to single use or disposable devices. |
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| Other identifier | Other identifier: Unspecified identifier, which can be further specified in a template or at run time.
Coding of the name of the identifier with a coding system is desirable, if available. |
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| Medical device details | Medical device details: Specific details that relate to asset management for any medical device that is designed for more than a single use. |
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| Organisation identifier | Organisation identifier: Organisation identifier for device.
May be a text string or an IEEE EUI-64 identifier.
 Text Identifier
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| Owner | Owner: Organisation responsible for the medical device. |
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| Location | Location: Physical location where device is kept. |
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| Network address | Network address: Network address to contact the device. |
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| Part number | Part number: The part number of the device. |
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| Manufacturer model name | Manufacturer model name: HL7 CDA compatible representation of device manufacture details.
May be a simple string or contain simple markup e.g. for Continua PHMR reports:
"Pulse Master 2000||584216|69854|2.1|1.1|1.0|"
repesenting Model, Unspecified, SerialNumber, PartNumber, HardwareRevision, SoftwareRevision, ProtocolRevision, and ProdSpecGMDN. |
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| Hardware revision | Hardware revision: The hardware revision number. |
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| Protocol revision | Protocol revision: The protocol revision number. |
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| Sampling frequency | Sampling frequency: The sampling frequency limits of the device.
- Text
 Quantity
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| Range | Range: The range limits of the device.
- Text
 Interval of Quantity
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| Accuracy | Accuracy: The accuracy limits of the device.
- Text
- Quantity
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| Resolution | Resolution: The resolution limits of the device.
- Text
- Quantity
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| Regulatory status | Regulatory status: Whether device is regulated or otherwise. |
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| Date last cleaned/sterilized | Date last cleaned/sterilized: Date the device was last cleaned or sterilized. |
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| Date last calibrated | Date last calibrated: Date the device was last calibrated. |
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| Date last serviced | Date last serviced: The date the device was last serviced. |
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| Formulae | Formulae: Details about formulae or algorithms used by the device in order to generate results/output. |
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| Formula name | Formula name: Data element which is calculated or derived. |
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| Formula | Formula: Formula used to calculate or derive the Calculated field. |
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| Comment | Comment: Additional narrative about the device not captured in other fields. |
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| Acquisition details on ophthalmic tomography | Acquisition details on ophthalmic tomography: Defines specific details about ophthalmic tomography studies. |
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| Laterality | Laterality: Eye/s included in the study.
- Left eye
- Right eye
- Both eyes
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| Acquisition method | Acquisition method: Acquisition method chosen to perform the ophthalmic tomography study. It is based on the Table CID 4210 of DICOM standard.
- Optical Coherence Tomography Scanner
- Retinal Thickness Analyzer
- Confocal Scanning Laser Ophthalmoscope
- Scheimpflug Camera
- Scanning Laser Polarimeter
- Elevation-based corneal tomographer
- Reflection-based corneal topographer
- Interferometry-based corneal tomographer
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| Study outcome | Study outcome: Identifies the type of analyses which must be obtained from the study.
- Transverse image overview
- 3D reconstruction image analysis
- Video angiography
- Thickness analysis
- Thickness evolution along-time (follow-up)
- Thickness classification (measured vs normative)
- Asymmetry analysis
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| Predefined scan | Predefined scan: Choice among predefined settings provided by the ophthalmic tomography for scanning the eye structure. |
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| Study type | Study type: Subject of study of the ophthalmic tomography.
- Angle
- Cornea
- Iris
- Sclera
- Glaucoma
- Retina
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| Predefined scans | Predefined scans: Choice of a predefined scan patterns from the device to conduct the study.
- Angle 1 ACA
- Angle 2 ACA
- Angle small
- Cornea dense
- Cornea large
- Cornea scan 08
- Cornea scan 11
- Cornea small
- Sclera dense
- Sclera large
- Sclera scan 08
- Sclera scan 11
- Sclera small
- Sclera vol. bleb
- Glaucoma dense
- Glaucoma Fast
- Glaucoma ONH
- Glaucoma P. Pole
- Glaucoma RNFL
- Retina 7 lines
- Retina dense
- Retina detail
- Retina fast
- Retina Fast HR
- Retina Lin HR
- Retina P. Pole
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| Custom scan | Custom scan: Description of characteristics for a personalized scan. |
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| Scan pattern | Scan pattern: Defines the pattern used to scan structures inside the eye.
- Single
- Radial
- Star
- High speed multi-frame
- High resolution multi-frame
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| Position of scan pattern | Position of scan pattern: Eye structure in which the scan is centred.
Value set: ac0001 |
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| Scan size (width or diameter) | Scan size (width or diameter): Width of the frame (or diameter in case of circle scan pattern).
Units: ° (UCUM: deg) |
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| Scan size (height) | Scan size (height): Height of the frame.
Units: ° (UCUM: deg) |
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| Distance between sections | Distance between sections: Distance between sections scanned consecutively.
Units: μm (UCUM: um) |
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| Section scans | Section scans: Number of sections included in the scan.
>=1 |
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| Other contributors | jose.andonegui.navarro@cfnavarra.es; Luis Serrano, Universidad Pública de Navarra (UPNA), lserrano@unavarra.es; Jesús D. Trigo, Universidad Pública de Navarra (UPNA), jesusdaniel.trigo@unavarra.es |
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