Condition category
Eye Diseases
Date applied
18/12/2018
Date assigned
21/01/2019
Last edited
21/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://www.uminho.pt/PT

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

Publication citations

Additional files

Editorial Notes