NCT03081468

The PUPIL Study - Automated, Quantitative Pupil Assessment Using Binocular OCT

Completed Last updated 6 April 2018

What this trial tests

trial testing Binocular OCT prototype in Healthy Volunteers in 100 participants. Completed in 30 November 2017.

Timeline

18 May 2017

Primary endpoint
30 November 2017

30 November 2017

Quick facts

Lead sponsor	University College, London
Status	Completed
Study type	OBSERVATIONAL
Enrollment	100
Start date	18 May 2017
Primary completion	30 November 2017
Estimated completion	30 November 2017
Sites	1 location across United Kingdom

Drugs / interventions tested

• Binocular OCT prototype
• Konan RAPDx

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →
• Relative Afferent Pupil Defect — all drugs for Relative Afferent Pupil Defect →
• Pupil Anomaly — all drugs for Pupil Anomaly →

Sponsor

University College, London

Who can join

18 and older, any sex, with Healthy Volunteers or Relative Afferent Pupil Defect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In current, clinical ophthalmology, a range of specialised testing allows comprehensive evaluation of ocular health. These tests have typically evolved over many years to ensure their clinical validity. For example, the assessment of visual acuity has traditionally been measured with Snellen letter charts from a distance of six metres (20 feet), leading to the phrase "20/20 vision". Despite this, the limitations of Snellen testing are well established and more sophisticated testing is now available (e.g., logMAR testing using ETDRS (Early Treatment Diabetic Retinopathy Study) charts). Many other diagnostic tests have undergone similar cycles of refinement, often over extended time periods. Therefore, it should be incumbent on any new device to undergo detailed evaluation of its validity (how its measurements agree with other testing) and its repeatability (the variability when a further measurement is obtained in short time period, by the same operator and under the same conditions).

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.

This study will assess the validity and repeatability of pupil measurements using binocular OCT.

Publications & conference data

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