Characterization of problems associated with vision impairment and utility of the current interventions
| ISRCTN | ISRCTN10894889 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10894889 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/12/2018
- Registration date
- 21/01/2019
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
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 December 2021
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
Contact information
Scientific
Linnaeus University
Department of Medicine and Optometry
Smålandsgatan 26 A
Kalmar
39234
Sweden
 ORCID ID |
0000-0003-3436-2010 |
|---|---|
| Phone | +351 (0)768805972 |
| a.macedo@ucl.ac.uk |
Scientific
University of Minho
Departmento de Fisica
Campus de Gualtar
Braga
4710 - 057
Portugal
| ORCID ID |
0000-0001-6623-9151 |
|---|
Study information
| Study design | Randomised cross-over controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, pelase use contact details to request a participant information sheet |
| Scientific title | Cost-effectiveness of basic vision rehabilitation services (the basic VRS-effect study): a cross-over randomised controlled trial |
| Study acronym | The basic VRS-effect study |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 02/09/2016 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 88 participants (44 per group). |
| Total final enrolment | 47 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 03/03/2017 |
| Date of final enrolment | 30/03/2020 |
Locations
Countries of recruitment
- Portugal
Study participating centre
Braga
4710-057
Portugal
Sponsor information
University/education
Department of Physics
Braga
4710-057
Portugal
| Website | https://www.uminho.pt/PT |
|---|---|
"ROR" |
https://ror.org/037wpkx04 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication: Protocol: 29/03/2019 Results: 2019, 2020, 2021 |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/05/2020 | 14/02/2020 | Yes | No |
| Interim results article | Association between social support and depression and anxiety | 03/03/2021 | 07/09/2021 | Yes | No |
| Interim results article | Association between depression and anxiety and health-related quality of life | 10/02/2022 | 25/07/2022 | Yes | No |
| Results article | 11/11/2022 | 14/11/2022 | Yes | No |
Editorial Notes
14/11/2022: Publication reference added.
25/07/2022: Publication reference added.
18/10/2021: The total final enrolment number was added and the intention to publish date was changed from 30/09/2021 to 01/03/2022.
07/09/2021: The overall trial end date was changed from 30/09/2020 to 31/12/2021.
14/02/2020: Publication reference added.
