Adolescent Development, Child, Vision, Low
Conditions
Brief summary
This pilot randomized controlled trial (RCT) will test the methodology for a full RCT of assistive technologies for children/young people with low vision/blindness. The investigators will recruit 40 students age 10-18 years in India and the UK, who will be randomised into two groups. Apple iPads will be the active intervention; the control arm will be the local standard low-vision aid care. Primary outcomes will be acceptance/usage and accessibility of the device and trial feasibility measures. Exploratory outcomes will be validated measures of vision-related quality of life for children/young people as well as validated measures of reading and educational outcomes. In addition, the investigators will carry out semistructured interviews with the participants and their teachers, and attempt to evaluate cost-effectiveness.
Interventions
DEVICETablet computer
iPad
Sponsors
L.V. Prasad Eye Institute
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: * age 10-18 years * low vision, defined as best corrected visual acuity (BCVA) for distance between - less than 6/18 (0.48 logMAR) and 3/60 (1.30 logMAR) in the better eye (WHO) ability to read printed material * no previous or current use of a tablet computer for educational purposes We will include students who have access to a tablet computer already, but only use it for recreational purposes. We will also include students who use a laptop. We will also include students who use or have previously used optical low-vision aids such as magnifiers, telescopes and CCTV systems.
Exclusion criteria
* current or previous use of a tablet computer for educational purposes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| acceptance/usage, measured as ordinal variable by participant diary | six months | 0 = no acceptance, 1 = acceptance as described, 2 = used frequently |
| accessibility measured as ordinal variable as score on a touch-based game, Piano Tiles | six months | 0 = not accessible, 1 = accessible with help, 2 = accessible independently |
| recruitment rates into the trial | six months | recruitment rate and reasons for not taking part |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neale Analysis of Reading Ability (NARA) | six months | reading accuracy, comprehension and speed |
| Cardiff Visual Ability Questionnaire for Children (CVAQC) score | six months | Functional visual ability scale, for participants in the UK |
| International Reading Speed Texts (IREST) | six months | reading speed |
| LV Prasad Functional Vision Questionnaire | six months | Vision related quality of life scale, for participants in India |
| Impact of Vision Impairment for Children (IVI_C) Questionnaire | six months | Functional vision, all participants |
Countries
India, United Kingdom
Contacts
Primary ContactSuzanne Emerton
Outcome results
None listed