Healthy VolunteersNCT03081468
The PUPIL Study - Automated, Quantitative Pupil Assessment Using Binocular OCT
An observational study of Healthy Volunteers and Relative Afferent Pupil Defect, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Relative Afferent Pupil Defect, Pupil Anomaly
- What is being tested?
- Binocular OCT prototype and Konan RAPDx
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 May 2017to 30 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Single-Site Non-Interventional Study to Evaluate the Diagnostic Accuracy and Repeatability of Pupil Measurements Using a Prototype Binocular Optical Coherence Tomography System.
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.
Read the detailed description
Binocular OCT has the potential to allow for objective, quantitative measurement of pupillary reflexes, that can be performed in a fast, safe, and automated manner. Importantly, binocular OCT pupillometry can be performed alongside binocular retinal OCT imaging in a single testing session, in an automated manner (imaging of the retina using OCT is the commonest ophthalmic imaging procedure worldwide - in 2011, it is estimated that more than 20 million retinal OCT images were obtained, more than the sum of all other ophthalmic imaging procedures combined).
Assessment of pupillary reflexes is an essential component of a comprehensive ocular examination. In patients with visual loss, for example, detection of an RAPD often indicates the presence of serious ophthalmic diseases, such as optic neuropathies or severe retinal disease. As such, RAPD testing is essential as a screening test in the assessment of patients with less serious conditions such as cataract.
RAPD testing is commonly performed using the swinging flashlight method (SFM). A positive SFM test suggests the presence of asymmetric damage involving the afferent limb of the pupillary light reflex pathway. The SFM is a qualitative test, and relies upon visualising no pupillary constriction or immediate or delayed pupillary dilation; if either of these responses is observed, an RAPD is believed to be present. The SFM requires a trained examiner and many potential sources of error may confound the results, including anisocoria, off-axis pupil illumination, and unequal retinal bleaching. Pupil abnormalities may be subtle and easily missed using the SFM.
Automated pupilometers allow examiners to precisely and objectively quantify the pupillary response to light by measuring parameters such as minimum and maximum pupil diameter, the amplitude of constriction, latency of constriction, velocity of constriction, and duration of maximum constriction. Dedicated pupillometry devices are commercially available and have been shown to be highly sensitive and specific for RAPD detection e.g. RAPDx; Konan Medical USA, Inc., Irvine, CA. These devices are also capable of detecting the presence of more subtle RAPD, typically not found using the SFM, in diseases such as glaucoma.
Unfortunately, automated pupilometers such as the Konan RAPDx system are not widely used in clinical practice. This is largely because they are expensive devices, limited to a single purpose. A binocular OCT system that could perform both automated pupillometry and retinal OCT imaging would thus have great clinical utility.
- Being tested
- Binocular OCT prototype, Konan RAPDx
- Keywords
- Optical coherence tomography, Pupillometry, Automated, Binocular
- Medical subject headings
- Pupil Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binocular OCT prototypeDevice
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).
Konan RAPDxDevice
Participants in the study will undergo pupil measurement using a validated, commercially available pupilometer (RAPDx; Konan Medical USA, Inc., Irvine, CA).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Binocular OCT prototype; Device: Konan RAPDx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (1)
Test-retest variability of the binocular OCT pupillometry assessment
The secondary objective will be to assess the repeatability (test-retest variability) of pupillary assessment using this prototype binocular OCT system.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start18 May 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081468
- Sponsor's protocol ID
- 16/0578
- Status last verified
- Apr 2018
- First submitted
- 10 Mar 2017
- Last updated
- 6 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Site Non-Interventional Study to Evaluate the Diagnostic Accuracy and Repeatability of Pupil Measurements Using a Prototype Binocular Optical Coherence Tomography System.
- ClinicalTrials.gov ID
- NCT03081468
- Acronym / sponsor ID
- 16/0578
- Keywords
- Optical coherence tomography, Pupillometry, Automated, Binocular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 18 May 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Binocular OCT has the potential to allow for objective, quantitative measurement of pupillary reflexes, that can be performed in a fast, safe, and automated manner. Importantly, binocular OCT pupillometry can be performed alongside binocular retinal OCT imaging in a single testing session, in an automated manner (imaging of the retina using OCT is the commonest ophthalmic imaging procedure worldwide - in 2011, it is estimated that more than 20 million retinal OCT images were obtained, more than the sum of all other ophthalmic imaging procedures combined).
Assessment of pupillary reflexes is an essential component of a comprehensive ocular examination. In patients with visual loss, for example, detection of an RAPD often indicates the presence of serious ophthalmic diseases, such as optic neuropathies or severe retinal disease. As such, RAPD testing is essential as a screening test in the assessment of patients with less serious conditions such as cataract.
RAPD testing is commonly performed using the swinging flashlight method (SFM). A positive SFM test suggests the presence of asymmetric damage involving the afferent limb of the pupillary light reflex pathway. The SFM is a qualitative test, and relies upon visualising no pupillary constriction or immediate or delayed pupillary dilation; if either of these responses is observed, an RAPD is believed to be present. The SFM requires a trained examiner and many potential sources of error may confound the results, including anisocoria, off-axis pupil illumination, and unequal retinal bleaching. Pupil abnormalities may be subtle and easily missed using the SFM.
Automated pupilometers allow examiners to precisely and objectively quantify the pupillary response to light by measuring parameters such as minimum and maximum pupil diameter, the amplitude of constriction, latency of constriction, velocity of constriction, and duration of maximum constriction. Dedicated pupillometry devices are commercially available and have been shown to be highly sensitive and specific for RAPD detection e.g. RAPDx; Konan Medical USA, Inc., Irvine, CA. These devices are also capable of detecting the presence of more subtle RAPD, typically not found using the SFM, in diseases such as glaucoma.
Unfortunately, automated pupilometers such as the Konan RAPDx system are not widely used in clinical practice. This is largely because they are expensive devices, limited to a single purpose. A binocular OCT system that could perform both automated pupillometry and retinal OCT imaging would thus have great clinical utility.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: Binocular OCT prototype, Device: Konan RAPDxFifty 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. |
| Participants with confirmed relative afferent pupillary defect | – | Device: Binocular OCT prototype, Device: Konan RAPDxFifty 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binocular OCT prototypeParticipants 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 | Healthy volunteers, Participants with confirmed relative afferent pupillary defect |
| Konan RAPDxParticipants in the study will undergo pupil measurement using a validated, commercially available pupilometer (RAPDx; Konan Medical USA, Inc., Irvine, CA). | Device | Healthy volunteers, Participants with confirmed relative afferent pupillary defect |
Primary outcome
Diagnostic accuracy of the binocular OCT
Time frame: 6 months
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).
1 secondary outcome
Test-retest variability of the binocular OCT pupillometry assessment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers and Relative Afferent Pupil Defect, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the binocular OCT (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.