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

NCT03081468 | Completed

• 1 other identifier: 16/0578
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Optical coherence tomography; Pupillometry; Automated; Binocular

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the binocular OCT

  The primary objective will be to determine the diagnostic accuracy of a prototype binocular OCT system for the detection of relative afferent pupillary defect (RAPD).

  6 months

Secondary Outcomes (1)

• Test-retest variability of the binocular OCT pupillometry assessment

  6 months

Study Arms (2)

Healthy volunteers

Fifty healthy volunteers. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. Participants will undergo pupillometry examination using the binocular OCT prototype and Konan RAPDx.

Device: Binocular OCT prototype; Device: Konan RAPDx

Participants with confirmed relative afferent pupillary defect

Fifty participants with with eye disease (retinal disease, glaucoma, and neuro-ophthalmic conditions) and confirmed relative afferent pupillary defect. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. Participants will undergo pupillometry examination using the binocular OCT prototype and Konan RAPDx.

Device: Binocular OCT prototype; Device: Konan RAPDx

Interventions

Binocular OCT prototype DEVICE

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).

Healthy volunteers; Participants with confirmed relative afferent pupillary defect

Konan RAPDx DEVICE

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

Healthy volunteers; Participants with confirmed relative afferent pupillary defect

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with eye disease (retinal disease, glaucoma, and neuro-ophthalmic conditions), and confirmed relative afferent pupillary defect as measured with RAPDx, and participants with no ocular abnormality ("healthy volunteers") will be recruited for the study.

You may qualify if:

• Presence of RAPD as measured with RAPDx
• Presence of retinal disease, glaucoma or neuro-ophthalmic conditions that affect the optic nerve
• Male or female, aged 18 years or older
• Ability to understand nature/purpose of the study and to provide informed consent
• Ability to undergo binocular OCT imaging
• Ability to follow instructions and complete the study
• Ability to speak English

You may not qualify if:

• Optical media opacity sufficient to preclude adequate ocular imaging with OCT
• Ptosis (drooping of the upper eyelid) sufficient to preclude visualization of the pupils using OCT
• Significant pupil irregularity that precludes reliable measurement of RAPD
• Any condition that is likely to interfere with pupillary constriction (e.g., iris pathology)
• Hearing impairment sufficient to interfere with hearing instructions
• Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct.
• No self-reported ocular history (although wearing corrective prescription glasses is permitted)
• Male or female, aged 18 years or older
• Ability to understand nature/purpose of the study and to provide informed consent
• Ability to undergo binocular OCT imaging
• Ability to follow instructions and complete the study
• Ability to speak English
• Presence of ocular pathology, including ptosis or pupil irregularities
• Hearing impairment sufficient to interfere with hearing instructions
• Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Moorfields Eye Hospital NHS FT

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

Pupil Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 16, 2017
• Study Start: May 18, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: April 6, 2018

Record last verified: 2018-04

Locations

GB (1)