Intraocular pressure and visual field eCRF template
Ophthalmology data comes in pairs: right eye and left eye, with one designated as the study eye. This template records IOP by eye with method and time of day, and visual field results with the reliability indices that decide whether a test counts.
- Per-eye fields
- Time of day recorded
- Visual field reliability
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Time of measurement
IOPTIMMethod
IOPMETHIOP, right eye (OD)
IOPODIOP, left eye (OS)
IOPOSAt a glance
- Record each eye separately (OD and OS) and designate a study eye at baseline according to the protocol.
- Goldmann applanation tonometry is the usual reference method for IOP; record the method, because devices differ.
- IOP varies through the day, so trials measure at fixed times and compare like with like across visits.
- Central corneal thickness affects IOP readings and is usually measured at baseline.
- Visual field results need reliability indices (fixation losses, false positives, false negatives) as well as global indices such as mean deviation and pattern standard deviation.
In trials
Glaucoma trials measure pressure, then vision
Trials of glaucoma and ocular hypertension treatments usually use IOP reduction as the primary endpoint, measured at several fixed times of day at each visit to capture diurnal variation and the drug's duration of effect. Because the endpoint compares means at matching time points, the time of each measurement must be recorded and kept consistent.
Visual fields show whether vision is being preserved, which is what matters to patients. They are noisy, so trials use standardised automated perimetry, repeat tests to confirm change, and exclude unreliable tests using predefined reliability criteria. Store the reliability indices with each test so those rules can be applied.
Both eyes
Many ophthalmology trials treat both eyes but analyse one study eye, or analyse both with methods that account for the correlation between eyes. Either way, per-eye data with a clear study eye flag keeps the analysis straightforward.
Template
IOP and visual field fields
| Field | Per eye | Notes |
|---|---|---|
| Time of measurement | No | Fixed time points per visit |
| IOP method | No | Goldmann applanation or device used |
| IOP | Yes | mmHg; repeat readings if the protocol requires |
| Central corneal thickness | Yes | Micrometres; usually at baseline |
| Visual field test strategy | Yes | For example a standard 24-2 threshold test |
| Mean deviation and pattern standard deviation | Yes | Decibels |
| Reliability indices | Yes | Fixation losses, false positives, false negatives |
| Best-corrected visual acuity | Yes | Letters on a standard chart |
Adapt to your protocol and perimetry device.
In Capture
Per-eye fields with checks at entry
Build OD and OS fields side by side on one form, with units and range checks that raise an auto-query when a value falls outside the limits you set. Time and method fields sit on the same form, source data verification can be set per field for endpoint data, and every change is in the field-level audit trail.
- OD and OS fields side by side.
- Range checks with auto-queries.
- SDV per field on endpoint data.
- Date of birth
- Systolic blood pressure
- Diastolic blood pressure
- BMI (calculated)never verified
- Position during measurement
- Comments
Changed by Data manager · reason: critical safety value added
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Safety
Ocular safety data
Ophthalmic drugs are applied to the eye, so ocular safety is examined at every visit: slit-lamp findings, conjunctival hyperaemia graded on a standard scale, corneal staining, and visual acuity. Systemic drugs with possible ocular effects may also need eye examinations. Record ocular adverse events with the affected eye, so events can be analysed by eye.
Keep ocular examination forms consistent across sites and train assessors on grading scales. See the physical exam eCRF template for structuring examination findings.
Devices
Device models, imaging and central reading
Ophthalmology trials often add imaging such as optical coherence tomography of the optic nerve and retina, and fundus photography. Results from different devices and software versions are not always interchangeable, so record the device model and software version for perimetry and imaging, and keep them the same for each participant where possible.
Central reading centres commonly grade images and sometimes review visual fields. Store the site's results and the central read as separate variables, with the date each was produced, so the analysis uses the right one and disagreements can be reviewed. See EDC for medical device trials for device-related data.
Before go-live
IOP and visual field checklist
Study eye rule
Defined and recorded at baseline.
Time points
Fixed times at every visit.
Method
Tonometer type recorded; consistent per participant.
Perimetry standard
Test strategy and device fixed.
Reliability rules
Exclusion criteria in the analysis plan.
Ocular AEs
Affected eye recorded.
Should device models be recorded?
Yes. Perimetry and imaging results are not always interchangeable between devices and software versions.
How are central reads handled?
Store site results and central reads as separate variables, with dates.
Why record IOP for each eye separately?
Eyes can differ and may be treated differently. Per-eye data with a study eye flag supports the analysis.
Why does the time of measurement matter?
IOP varies through the day, so trials compare measurements at matching times.
What is the reference method for IOP?
Goldmann applanation tonometry is the usual reference method. Record the method used.
Why store visual field reliability indices?
Protocols exclude unreliable tests using criteria based on fixation losses and false responses.
Can SDV be set on endpoint fields?
Yes. Source data verification can be set per field.
Is the template free?
Yes. Copy it into your study in the free sandbox.
Ophthalmology data, eye by eye
Per-eye fields with checks and SDV. Free sandbox.