Study of a device for detecting diabetic eye disease

ISRCTN	ISRCTN11684778
DOI	https://doi.org/10.1186/ISRCTN11684778
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	EFS-A008/A009
Sponsor	Fraunhofer Portugal Research
Funder	Portugal 2020, framed under the Operational Program Competitiveness and Internationalization (COMPETE 2020) and European Regional Development Fund from European Union, with operation code POCI-01-0247-FEDER-038400

Submission date: 28/12/2021
Registration date: 30/12/2021
Last edited: 18/06/2024

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Diabetic retinopathy is a complication of diabetes caused by high blood sugar levels damaging the back of the eye (the retina). The EyeFundusScope is a smartphone-based eye fundus camera that has been developed to early detect diabetic retinopathy. This device can be used at home or in the offices of several health professionals who regularly have contact with patients with diabetes, such as family physicians and general practitioners, endocrinologists, nurses or optometrists. The aim of this study is to find out whether the EyeFundusScope can be used by physicians and nurses who are not specialists in ophthalmology to screen patients with diabetes for diabetic retinopathy.

Who can participate?
Patients aged 18-90 years old with diabetes

What does the study involve?
Physicians and nurses who are not specialised in ophthalmology will take pictures of patients' retinas with the EyeFundusScope.

What are the possible benefits and risks of participating?
Benefits: free ophthalmology consultation if the test result with EyeFundusSope is positive for diabetic retinopathy or other important findings, and reinforcement of the need to attend the next screening by the Portuguese National Health Service, even if the test result with EyeFundusScope is negative.
Risks: No significant risks are foreseen arising from participation in this study and the possible risks are mitigated by the researchers through measures of risk management.

Where is the study run from?
CUF Descobertas Hospital (Portugal)

When is the study starting and how long is it expected to run for?
September 2019 to November 2022

Who is funding the study?
This work is supported by "EyeFundusScopeNEO: Demonstration of EyeFundusScope with Non-Expert Ophthalmology Users", co-funded by Portugal 2020, framed under the Operational Program Competitiveness and Internationalization (COMPETE 2020) and European Regional Development Fund from European Union, with operation code POCI-01-0247-FEDER-038400.

Who is the main contact?
1. Francisco Nunes, francisco.nunes@fraunhofer.pt
2. Sílvia Rêgo, silvia.rego@fraunhofer.pt

Contact information

Prof Francisco Nunes
Principal investigator

Rua Alfredo Allen, 455-461
Porto
4200-135
Portugal

Phone	+351 (0)220430328
Email	francisco.nunes@fraunhofer.pt

Dr Sílvia Rêgo
Scientific

Rua Alfredo Allen, 455-461
Porto
4200-135
Portugal

Phone	+351 (0)220430347
Email	silvia.rego@fraunhofer.pt

Study information

Primary study design	Observational
Study design	Cross-sectional study
Secondary study design	Cross sectional study
Study type	Participant information sheet
Scientific title	Implementation and evaluation of a mobile retinal image acquisition system for screening diabetic retinopathy
Study objectives	A smartphone-based handheld eye fundus camera can be used by physicians and nurses not specialists in ophthalmology to screen individuals with diabetes for diabetic retinopathy.
Ethics approval(s)	1. Approved 31/07/2018, Ethics Commission of ARS Norte (Rua de Santa Catarina, 1288, 4000-447 Porto, Portugal; +351 22 041 10 00; etica@arsnorte.min-saude.pt), ref: 115/2018 2. Approved 21/12/2019, Ethics Committee of CUF Descobertas Hospital (Rua Mário Botas, 1998-018 Lisbon, Portugal; +351 (0)21 002 5200; marta.barreiros@cuf.pt), ref: not applicable
Health condition(s) or problem(s) studied	Diabetic retinopathy
Intervention	In this study, individuals with diabetes will be assessed for diabetic retinopathy with the smartphone-based handheld fundus camera EyeFundusScope (Fraunhofer AICOS, Portugal) operated by non-ophthalmic physicians and nurses.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	-
Primary outcome measure(s)	Diagnostic accuracy of EyeFundusScope for diabetic retinopathy screening, measured using sensitivity, specificity, predictive values and likelihood ratios at the time of retinal image acquisition
Key secondary outcome measure(s)	1. Image quality measured in four levels and classified by ophthalmologists at the time of retinal image acquisition 2. Technological functioning measured using the number of eyes in which it was not possible to acquire images, and the number of technical failures of both the EyeFundusScope and the information system, at the time of retinal image acquisition 3. Usability of the EyeFundusScope measured using the proportion of healthcare professionals who report ease of use, the score of the System Usability Scale, qualitative analyses of the observation and the mean time required to perform retinal image acquisition with the EyeFundusScope, at the time of retinal image acquisition 4. Acceptance of the EyeFundusScope measured using questionnaires and qualitative analysis of interviews and observations at the time of retinal image acquisition 5. The association of patients’ clinical characteristics with the accuracy and the quality of the images of the EyeFundusScope, measured using odds ratios at the time of retinal image acquisition 6. Inter and intra-operator agreement and reliability of the EyeFundusScope measured using kappa statistics and overall observed agreement at the time of retinal image acquisition 7. Ground truth optimization for the training of the algorithms before the calculation of measures listed above
Completion date	30/11/2022
Reason abandoned (if study stopped)	Objectives no longer viable

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	90 Years
Sex	All
Target sample size at registration	578
Key inclusion criteria	1. Diabetes mellitus diagnosis 2. 18-90 years old
Key exclusion criteria	1. Blindness 2. Strabismus 3. Retinal detachment 4. Blepharospasm 5. No autonomy to remain seated 6. Sensitivity to light due to medication, recent photodynamic therapy, or other reason 7. Pregnant or breastfeeding women
Date of first enrolment	15/06/2022
Date of final enrolment	30/09/2022

Locations

Countries of recruitment

Portugal

Study participating centres

CUF Tejo Hospital

Av. 24 de Julho 171A
Lisbon
1350-352
Portugal

ACES Grande Porto II - Gondomar

Rua Actor Mário Viegas
Rio Tinto
Porto
4435-076
Portugal

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	Participant-level data will be stored at the sponsor's information system and will not be made publicly available to protect participant privacy, as the study site is relatively small within the Portuguese healthcare system.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/06/2024: The trial was stopped as the objectives were no longer viable without having starting recruitment.
15/07/2022: The recruitment end date has been changed from 30/07/2022 to 30/09/2022.
21/04/2022: The recruitment start date has been changed from 15/04/2022 to 15/06/2022.
21/02/2022: The recruitment start date has been changed from 15/02/2022 to 15/04/2022.
04/01/2022: The following changes have been made:
1. CUF Descobertas Hospital has been removed from the trial participating centres and CUF Tejo Hospital and ACES Grande Porto II - Gondomar have been added.
2. ARS Norte Ethics Commission has been added to the ethics approvals.
30/12/2021: Trial's existence confirmed by the Ethics Committee of CUF Descobertas Hospital.