Status:
UNKNOWN
The ARUTIS Study (Anglia Ruskin University Trial of the Intuitive System)
Lead Sponsor:
Anglia Ruskin University
Conditions:
Visual Stress
Eligibility:
All Genders
9-18 years
Phase:
NA
Brief Summary
The goal of this double-masked randomised controlled trial (RCT) is to assess the symptoms of visual stress (VS), reading speed and changes in behaviour / academic performance, when wearing optimal Pr...
Detailed Description
The ARUTIS study is a double-masked randomised controlled trial (RCT) having a double-masked crossover (AB/BA) design. The study aims to assess the symptoms of visual stress (VS), reading speed and ch...
Eligibility Criteria
Inclusion
- Age 9-18y.
- Meet diagnostic indicators for visual stress (see below)
- Consent (parent and participant to attend for optometric testing and participate in research.
- Do not anticipate moving from the area in the next 3 months
- Diagnostic indicators for visual stress
- At least three of the following six typical symptoms:
- Words Move
- Words Merge
- Patterns or shadows in text (e.g., "rivers")
- Text seems to stand out in 3-D above the page
- Words or letters fade or darken
- Discomfort with certain artificial lights and flicker
- And "At least two of the following three signs from investigations:
- Voluntary unprompted use of an overlay for 3 months or more
- Overlay improves performance at the WWRT BY ≥15%
- PGT result \>3 with mid spatial frequency grating.
Exclusion
- History of wearing precision tinted lenses.
- Ocular pathology, systemic pathology that is likely to worsen in the timescale of the study or cause transient blur (e.g., diabetes) or photosensitive epilepsy
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06093516
Start Date
October 30 2023
End Date
September 1 2024
Last Update
October 23 2023
Active Locations (1)
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1
Anglis Ruskin University
Cambridge, United Kingdom, RM2 6DH