Use of a smartphone camera to assess pupil response to light in neurocritical care – comparison with pen torch

ISRCTN ISRCTN53630869
DOI https://doi.org/10.1186/ISRCTN53630869
IRAS number 324539
Secondary identifying numbers IRAS 324539
Submission date
23/02/2023
Registration date
20/04/2023
Last edited
20/04/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
This study is designed to compare the accuracy of measuring eye pupil size. It will compare the current standard of care, which is a pentorch and subjective assessment by a bedside nurse, to a new smartphone application using the camera and light of the phone to measure pupil size and responsiveness.

Who can participate?
Patients admitted to a specialist neurocritical care unit

What does the study involve?
Participants will have their pupils assessed by both methods hourly (which is standard) for a maximum of 10 days, during the day only. Not measuring at night provides respite for the patient (they will still have pentorch assessments) and reduces research staffing resources.

What are the possible benefits and risks of participating?
The interventions are non-invasive and as such there are no risks to participants. The proposed benefit is earlier identification of changes in pupil response, both in terms of improvement and deterioration.

Where is the study run from?
John Radcliffe Hospital (UK)

When is the study starting and how long is it expected to run for?
October 2022 to April 2023

Who is funding the study?
Solvemed Inc. (UK)

Who is the main contact?
Dr Simon Raby, simon.raby@ouh.nhs.uk

Contact information

Dr Simon Raby
Principal Investigator

Neurocritical Care
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

ORCiD logoORCID ID 0000-0003-4886-9795
Phone +44 (0)1865741166
Email simon.raby@ouh.nhs.uk

Study information

Study designSingle-centre non-randomized trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleSmartphone Pupillometry in Neurocritical Care - Comparison against PenTorch: the SPIN_CAT trial
Study acronymSPIN-CAT
Study objectivesSmartphone pupillometry is more accurate than pentorch assessment of pupil responsiveness in neurocritical care patients.
Ethics approval(s)Approval pending, South Central - Oxford C REC
Health condition(s) or problem(s) studiedCritically ill patients admitted to neurocritical care
InterventionPatients will have pupillary assessments made by pentorch and smartphone pupillometry. Pentorch is routine and the smartphone application is the additional intervention. Each intervention will be performed hourly during the day shift, for a maximum of 10 days per patient.

Pupil traces will be processed by Solvemed to generate two indices per eye: baseline pupil diameter (millimetres), and pupil reactivity (binary – responsive or non-responsive). Measurement reliability for pentorch and Solvemed app (baseline diameter) will be computed independently, to give an r-squared statistic for each. The reliabilities will be compared using a Fisher-transformed Z-test. The validity of the app will be established by the correlation of the pentorch and app measures. The primary outcome is that the app offers improved reliability. To gauge efficiency, questionnaires to nursing staff will be analysed using qualitative nonparametric statistics.
Intervention typeDevice
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Solvemed Neurapeek
Primary outcome measurePupil diameter (millimetres) and pupil reactivity (binary – responsive or non-responsive) measured using the two modalities (pentorch and Solvemed smartphone application), performed hourly during the day shift, for a maximum of 10 days per patient
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/10/2022
Completion date01/04/2023

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants20
Key inclusion criteriaAny patient admitted to neurocritical care
Key exclusion criteriaPupillary assessment not possible due to ocular pathology
Date of first enrolment01/04/2023
Date of final enrolment01/04/2024

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Oxford Radcliffe Hospital NHS Trust
The John Radcliffe
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Sponsor information

Solvemed Inc.
Industry

82-88 Hills Rd
Cambridge
CB2 1LQ
England
United Kingdom

Phone +44 (0)7966663309
Email michal.wlodarski@solvemed.ai

Funders

Funder type

Industry

Solvemed Inc.

No information available

Results and Publications

Intention to publish date01/06/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in non-publicly available repository
Publication and dissemination planThe study will be published in a high-impact peer-reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository: Following video capture, the video is uploaded onto the company-owned Amazon S3 server storage space (the cloud storage), where the captured videos and any associated data are stored in Amazon SQL databases. To ensure the stored data is secure, company applies an industry-standard Hypertext Transfer Protocol Secure (HTTPS) encryption protocol for all traffic between its smartphones and AWS servers. In addition, company applies suitable company-level policies regarding the access levels and procedures regarding every Amazon AWS component, using appropriate Amazon roles and Amazon policies.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version 1.0 03/08/2022 07/03/2023 No No

Additional files

43271_PROTOCOL_V1.0_03Aug22.pdf

Editorial Notes

20/04/2023: Trial's existence confirmed by Solvemed Inc.