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| Name | Class |
|---|---|
| L.V. Prasad Eye Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assistive technology: tablet computer | Experimental | iPad tablet computers |
|
| Standard optical low vision devices | Active Comparator | standard optical devices including magnifiers, telescopes, CCTV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tablet computer | Device | iPad |
|
| Measure | Description | Time Frame |
|---|---|---|
| acceptance/usage, measured as ordinal variable by participant diary | 0 = no acceptance, 1 = acceptance as described, 2 = used frequently | six months |
| accessibility measured as ordinal variable as score on a touch-based game, "Piano Tiles" | 0 = not accessible, 1 = accessible with help, 2 = accessible independently | six months |
| recruitment rates into the trial | recruitment rate and reasons for not taking part | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiff Visual Ability Questionnaire for Children (CVAQC) score | Functional visual ability scale, for participants in the UK | six months |
| LV Prasad Functional Vision Questionnaire | Vision related quality of life scale, for participants in India |
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Inclusion Criteria:
Inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suzanne Emerton | Contact | 0044 203 447 7430 | Suzanne.Emerton@uclh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Annegret Dahlmann-Noor, PhD | Moorfields Eye Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meera and L B Deshpande Centre for Sight Enhancement, L V Prasad Eye Institute | Recruiting | Hyderabad | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30153236 | Derived | 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. | |
| 28637740 | Derived | 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. |
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| ID | Term |
|---|---|
| D015354 | Vision, Low |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| six months |
| Impact of Vision Impairment for Children (IVI_C) Questionnaire | Functional vision, all participants | six months |
| Neale Analysis of Reading Ability (NARA) | reading accuracy, comprehension and speed | six months |
| International Reading Speed Texts (IREST) | reading speed | six months |
| South Essex Partnership Foundation Trust - Child Development Centre Bedford | Active, not recruiting | Bedford | United Kingdom |
| Moorfields Eye Hospital | Recruiting | London | EC1V 2PD | United Kingdom |
|
| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |