A new high-resolution 3D imaging camera for the front of the eye

Clinical evaluation of a novel LiveOCT (Optical Coherence Tomography) device to improve the management of eye disease

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN35255420

Enrollment

Registered

2021-10-21

Start date

2021-11-30

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal diseases Eye Diseases

Interventions

In vivo non-contact imaging of the layers of the cornea using a new anterior segment LiveOCT imaging device. 2 slightly different variants will be used. The only difference between variant 1 (D1) and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 12 years or above 2. Diagnosis of either Fuchs endothelial corneal dystrophy (FECD) or corneal lamellar surgery, Keratoconus, or no known corneal disease (healthy volunteers)

Exclusion criteria

Exclusion criteria: 1. Nystagmus 2. Inability to provide informed consent

Design outcomes

Primary

Measure	Time frame
The clarity of the images produced by the OCT devices - specifically whether we can see the boundaries of the layers of the cornea such as Bowman's layer, epithelial layer, stroma, and endothelial layer, in comparison to existing OCT models (TOMEY CASIA SS-1000 and Heidelberg Spectralis), measured by the device operator objectively viewing images - and recording onto CRF whether these layers are visible or not at baseline, month 3 and month 6	—

Measure

Time frame

The clarity of the images produced by the OCT devices - specifically whether we can see the boundaries of the layers of the cornea such as Bowman's layer, epithelial layer, stroma, and endothelial layer, in comparison to existing OCT models (TOMEY CASIA SS-1000 and Heidelberg Spectralis), measured by the device operator objectively viewing images - and recording onto CRF whether these layers are visible or not at baseline, month 3 and month 6

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Secondary

Measure	Time frame
1. Repeatability/reproducibility of measurements using the LiveOCT device of structural parameters of the cornea, corneal surface contour and refractive power at baseline, month 3 and month 6. We will take 3 images for each participant, for each study visit on both of our 2 LiveOCT devices. We will compare the images (using criteria mentioned above for image quality) to assess reproducibility. For example - can you identify all the layers in every image taken? 2. Sensitivity and specificity of the LiveOCT device, using published grading systems specific to the main conditions of Fuchs Endothelial Corneal Dystrophy and keratoconus at baseline, month 3 and month 6. For keratoconus, the sensitivity of the LiveOCT will be assessed by its ability to detect the same diagnostic parameters of non-uniform and focal corneal thinning and irregular and non-asymmetric anterior and posterior corneal profiles currently measured using the Pentacam. For FECD, the sensitivity of the LiveOCT will be assessed by its ability to measure increases in corneal thickness and areas of corneal swelling, and excrescences (guttata) and thickening of Descemet's membrane in patients who have guttata evident with slit lamp bio microscopy and increased corneal thickness measured with the Pentacam. Specificity will be defined as the percentage in which the described diagnostic changes in the cornea for keratoconus and FECD are not apparent with the LiveOCT device. 3. Patient Experience of being scanned by the LiveOCT device, measured using a patient experience questionnaire to be filled in by participants at the end of each study session at baseline, month 3 and month 6. 4. Cost effectiveness of the LiveOCT device compared to existing OCT models (TOMEY CASIA SS-1000 and Heidelberg Spectralis) using a cost consequences analysis using data from visits at baseline, month 3 and month 6.	—

Measure

Time frame

1. Repeatability/reproducibility of measurements using the LiveOCT device of structural parameters of the cornea, corneal surface contour and refractive power at baseline, month 3 and month 6. We will take 3 images for each participant, for each study visit on both of our 2 LiveOCT devices. We will compare the images (using criteria mentioned above for image quality) to assess reproducibility. For example - can you identify all the layers in every image taken? 2. Sensitivity and specificity of the LiveOCT device, using published grading systems specific to the main conditions of Fuchs Endothelial Corneal Dystrophy and keratoconus at baseline, month 3 and month 6. For keratoconus, the sensitivity of the LiveOCT will be assessed by its ability to detect the same diagnostic parameters of non-uniform and focal corneal thinning and irregular and non-asymmetric anterior and posterior corneal profiles currently measured using the Pentacam. For FECD, the sensitivity of the LiveOCT will be assessed by its ability to measure increases in corneal thickness and areas of corneal swelling, and excrescences (guttata) and thickening of Descemet's membrane in patients who have guttata evident with slit lamp bio microscopy and increased corneal thickness measured with the Pentacam. Specificity will be defined as the percentage in which the described diagnostic changes in the cornea for keratoconus and FECD are not apparent with the LiveOCT device. 3. Patient Experience of being scanned by the LiveOCT device, measured using a patient experience questionnaire to be filled in by participants at the end of each study session at baseline, month 3 and month 6. 4. Cost effectiveness of the LiveOCT device compared to existing OCT models (TOMEY CASIA SS-1000 and Heidelberg Spectralis) using a cost consequences analysis using data from visits at baseline, month 3 and month 6.

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026