Plain English Summary
Background and study aims
The burden caused by vision loss can be reduced using targeted vision rehabilitation. Vision rehabilitation is intended to promote the best possible functional ability and the individual's ability to maintain their skills. However, there is still a lack of knowledge regarding the “value-for-money” of vision rehabilitation not only for people with impaired vision but also for the society. The aim of this study is to estimate the cost-effectiveness (value-for-money) of vision rehabilitation by measuring the consequences of rehabilitation for visual ability (visual ability is defined as the overall ability to perform activities that depends on vision).
Who can participate?
Adults diagnosed with diabetic retinopathy (DR) or age-related macular degeneration (AMD) with visual acuity between 0.4 - 0.1 (decimal scale) in the better-seeing eye. Participants must live in the community (not in nursing homes or other types of institution).
What does the study involve?
The study intervention consists of dispensing new glasses and magnifiers, defined as "vision aids" with minimal training. Instructions are provided in clinical settings with emphasis on reading tasks. Participants randomly allocated to the immediate intervention group receive the device in the first visit. Participants in the delayed intervention group receive the device after 3 months, in the second visit. All participants have a follow-up assessment at 3 month and at 9 months after receiving vision aids. During visits participants also need to response to questionnaires and to perform vision tests (none of them are invasive).
What are the possible benefits and risks of participating?
This study brings benefits to all participants because they will receive a basic vision rehabilitation intervention which includes new glasses and/or magnifiers with minimal training and instructions provided in clinical settings with emphasis on reading tasks. With the intervention procedures the patients won’t be exposed to any risk.
Where is the study run from?
The study is being run by the University of Minho and takes place in a single centre, a public hospital in Barcelos, Portugal
When is the study starting and how long is it expected to run for?
September 2016 to September 2020
Who is funding the study?
The ophthalmic lenses and part of the magnifiers are supported by Essilor Portugal
Who is the main contact?
1. Antonio Filipe Macedo
a.macedo@ucl.ac.uk; antonio.macedo@lnu.se
2. Laura Moreno
PhD student in University of Minho, Braga, Portugal
Trial website
Contact information
Type
Scientific
Primary contact
Dr Antonio Filipe Macedo
ORCID ID
http://orcid.org/0000-0003-3436-2010
Contact details
Linnaeus University
Department of Medicine and Optometry
Smålandsgatan 26 A
Kalmar
39234
Sweden
+351 (0)768805972
a.macedo@ucl.ac.uk
Type
Scientific
Additional contact
Miss Laura Moreno
ORCID ID
http://orcid.org/0000-0001-6623-9151
Contact details
University of Minho
Departmento de Fisica
Campus de Gualtar
Braga
4710 - 057
Portugal
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Cost-effectiveness of basic vision rehabilitation services (the basic VRS-effect study): a cross-over randomised controlled trial
Acronym
The basic VRS-effect study
Study hypothesis
The aim of the trial is to compare the effects and costs of “usual low vision care” with a “basic vision rehabilitation service (basic VRS)” on self-reported visual ability.
Hypothesis: A basic low vision intervention, consisting of prescription of new glasses, magnifiers and instructions, improves visual ability more than usual care.
Ethics approval
Life Sciences and Health of the University of Minho, 02/05/2017, ref: SECVS 147/2016
CEUM/SECVS – Secretariado
Att: Isabel Monteiro
Universidade do Minho – Reitoria
Campus de Gualtar, CPII, Piso 3
4710-057 Braga
Tel: +351 (0)253 601 700
Email: secvs@reitoria.uminho.pt
Registered in the Portuguese data protection authority, ref: 7012/ 2017
Study design
Randomised cross-over controlled trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, pelase use contact details to request a participant information sheet
Condition
Vision impairment caused by diabetic retinopathy or age-related macular degeneration
Intervention
To perform a cost-effectiveness analysis (CEA) of basic VRS the trialists designed a randomised, cross-over controlled trial (AB/BA structure), comparing the effects and costs of “usual low vision care” (which is not yet systematised in Portugal) with a “basic-VRS intervention” on self-reported visual ability.
Participants will be allocated to the immediate intervention group (IMI), which is represented by group A or to a delayed intervention group (DEI) represented by group B. Participants are allocated to the IMI or DEI to create the best possible match between the groups according to age and visual acuity. The sequence of randomization is done blocks of 4 to guarantee two participants for each group using four similar envelopes. Each envelope will contain the code of the group, two envelopes for IMI and two for DEI group. The study takes place in a single-centre.
The intervention consists of dispensing new glasses and magnifiers, defined as "vision aids", with minimal training and instructions provided in clinical settings with emphasis on reading tasks. Participants allocated to the immediate intervention group will receive the device in the first visit. Participants in the delayed intervention group will receive the device after 3 months, in the second visit. All participants will have a follow-up assessment at 3 months and at 9 months after receiving vision aids.
Intervention type
Device
Phase
Drug names
Primary outcome measure
Measured at baseline, 12 weeks and 36 weeks:
1. Visual ability, measured using Massof Activity Inventory (AI)
2. Health-related quality of life, measured using EQ-5D-5L
Secondary outcome measures
Measured at baseline, 12 weeks and 36 weeks:
1. Reading ability, measured using Portuguese version of Minnesota Low-Vision Reading Test (MNread test)
2. Depression and anxiety, measured using Hospital Anxiety and Depression Scale (HADS)
Overall trial start date
02/09/2016
Overall trial end date
30/09/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Visual acuity between 0.4 - 1.0 logMAR (0.4 - 0.1 decimal) in the better-seeing eye
2. Primary diagnosis (cause of vision loss) diabetic retinopathy or age-related macular degeneration
3. 18 years of age or older
4. Resident in the community (not in nursing homes or other types of institution)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
88 participants (44 per group).
Participant exclusion criteria
1. Cognitive impairment based on scores on mini-mental examination test
2. Communication problems due to, for example, hearing impairment, or unable to speak Portuguese
3. Unable to read in Portuguese due to low level of education
4. Unable to attend the requested appointments at the study setting
Recruitment start date
03/03/2017
Recruitment end date
30/03/2020
Locations
Countries of recruitment
Portugal
Trial participating centre
University of Minho
Campus de Gualtar
Braga
4710-057
Portugal
Sponsor information
Organisation
University of Minho
Sponsor details
Department of Physics
Braga
4710-057
Portugal
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication:
Protocol: 29/03/2019
Results: 2019, 2020, 2021
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
30/09/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2020 protocol in https://www.ncbi.nlm.nih.gov/pubmed/31989690 (added 14/02/2020)