Clinical trial NCT02798848: CREATE - Children Reading With Electronic Assistance To Educate
Official title: Tablet Computers Versus Optical Aids to Support Education and Learning in Children and Young People With Low Vision: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vision, Low
Child
Adolescent Development
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: L.V. Prasad Eye Institute
First posted: 2016-06-14
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: acceptance/usage, measured as ordinal variable by participant diary
timeFrame: six months
measure: accessibility measured as ordinal variable as score on a touch-based game, "Piano Tiles"
timeFrame: six months
measure: recruitment rates into the trial
timeFrame: six months
Secondary outcomes:
measure: Cardiff Visual Ability Questionnaire for Children (CVAQC) score
timeFrame: six months
measure: LV Prasad Functional Vision Questionnaire
timeFrame: six months
measure: Impact of Vision Impairment for Children (IVI_C) Questionnaire
timeFrame: six months
measure: Neale Analysis of Reading Ability (NARA)
timeFrame: six months
measure: International Reading Speed Texts (IREST)
timeFrame: six months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Meera and L B Deshpande Centre for Sight Enhancement, L V Prasad Eye Institute
city: Bedford
country: United Kingdom
facility: South Essex Partnership Foundation Trust - Child Development Centre Bedford
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
Study officials:
affiliation: Moorfields Eye Hospital NHS Foundation Trust
name: Annegret Dahlmann-Noor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gothwal VK, Thomas R, Crossland M, Bharani S, Sharma S, Unwin H, Xing W, Khabra K, Dahlmann-Noor A. Randomized Trial of Tablet Computers for Education and Learning in Children and Young People with Low Vision. Optom Vis Sci. 2018 Sep;95(9):873-882. doi: 10.1097/OPX.0000000000001270.
citation: Crossland MD, Thomas R, Unwin H, Bharani S, Gothwal VK, Quartilho A, Bunce C, Dahlmann-Noor A. Tablet computers versus optical aids to support education and learning in children and young people with low vision: protocol for a pilot randomised controlled trial, CREATE (Children Reading with Electronic Assistance To Educate). BMJ Open. 2017 Jun 21;7(6):e015939. doi: 10.1136/bmjopen-2017-015939.