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Characterization of problems associated with vision impairment and utility of the current interventions

Cost-effectiveness of basic vision rehabilitation services (the basic VRS-effect study): a cross-over randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10894889
Enrollment
88
Registered
2019-01-21
Start date
2017-03-03
Completion date
Unknown
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vision impairment caused by diabetic retinopathy or age-related macular degeneration Eye Diseases

Interventions

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 car

Sponsors

University of Minho
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026