MedTrace Logo

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

NCT03081468 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2018-04-06

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers
  • Relative Afferent Pupil Defect
  • Pupil Anomaly

Interventions

DEVICE

Binocular OCT prototype

Participants in the study will undergo pupil measurement using a prototype binocular OCT imaging system (Envision Diagnostics, Inc., CA). For the binocular OCT imaging system, testing will be performed twice in the same session, by the same examiner, to allow assessment of repeatability (test-retest variability).

DEVICE

Konan RAPDx

Participants in the study will undergo pupil measurement using a validated, commercially available pupilometer (RAPDx; Konan Medical USA, Inc., Irvine, CA).

Sponsors & Collaborators

  • University College, London

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-18
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03081468 on ClinicalTrials.gov