NCT03553017

The EXPLORE Study - The Use of Binocular OCT Imaging for the Assessment of Ocular Disease

Completed Last updated 19 October 2020

What this trial tests

trial testing Binocular OCT in Eye Diseases in 70 participants. Completed in 1 March 2020.

Timeline

22 May 2018

Primary endpoint
1 March 2020

1 March 2020

Quick facts

Lead sponsor	University College, London
Status	Completed
Study type	OBSERVATIONAL
Enrollment	70
Start date	22 May 2018
Primary completion	1 March 2020
Estimated completion	1 March 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• Binocular OCT

Conditions studied

• Eye Diseases — all drugs for Eye Diseases →
• Eye Infections — all drugs for Eye Infections →
• Eye Inflammation — all drugs for Eye Inflammation →

Sponsor

University College, London

Who can join

18 and older, any sex, with Eye Diseases or Eye Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Optical coherence tomography (OCT) is an imaging modality, first described in 1991, that provides cross-sectional images of the eye in a non-invasive manner. OCT is analogous to ultrasonography but measures the "echoes" of light waves rather than sound and, as a result, generates extremely high-resolution images (\~5 μm axial resolution). Although OCT has already proven revolutionary in ophthalmology, current OCT systems are large, expensive, and require skilled personnel for image acquisition and interpretation. Furthermore, current OCT systems are limited to examination of specific regions of single eyes - for example, separate devices are typically required for anterior segment (e.g., cornea) versus posterior segment (e.g., retina) imaging. A new form of OCT imaging has recently been developed - so-called "binocular" optical coherence tomography (OCT) (Envision Diagnostics, Inc., California).1,2 Binocular OCT addresses many of the short-comings of conventional OCT devices.

Binocular OCT extends the application of OCT devices beyond that of simple, cross- sectional imaging to a diverse array of diagnostic tests. The binocular design also removes the need for additional personnel to perform testing (i.e., the device can be self-operated in an automated manner), and allows for novel testing to be performed that is not possible with monocular imaging. In particular, binocular OCT devices have the potential to perform automated, quantitative pupillary measurements - an entirely novel application for this imaging modality, plus also adds a number of unique capabilities. In particular, binocular OCT removes the need for additional personnel to acquire the images by enabling patients to align the optical axes of the instrument with the optical axes of their own eyes. The system also employs recently developed "swept-source" lasers as its light source, allowing it to see deeper into the eye than conventional OCT systems. Finally, binocular OCT systems allow image capture from both eyes at the same time. This "simultaneous" ocular imaging extends the range of diagnostic testing possible, allowing for features such as pupillometry and ocular motility.

The greatly increased range of imaging for these lasers enables the entire depth of eye tissue to be captured in just a few sequences of images - so- called "whole eye" OCT or "OCT ophthalmoscopy".

In this study, the investigators aim to explore the unique imaging features of the binocular OCT to describe novel features across a range of diseases. The repeatability of quantifying various parameters in the images acquired using the system will be assessed.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.