Trials · 2025
The ARUTIS Study (Anglia Ruskin University Trial of the Intuitive System): a single-centre, double-masked randomised controlled crossover trial of precision tinted lenses for visual stress: study protocol for a randomised controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Ramsahye Zahra N, Allen Peter M, Thomas Nikita J, Wilkins Arnold J, Evans Bruce J W, Gilchrist James M
Аннотация
BACKGROUND: Visual stress (VS), a condition affecting approximately 20% of children with reading difficulties that is alleviated with individually prescribed coloured filters, remains controversial. The purpose of the Anglia Ruskin University Trial of the Intuitive System (ARUTIS) is to investigate the effect of wearing precision tinted lenses (PTL) prescribed by the Intuitive System (IS) in children with VS using a double-masked crossover design.
METHODS: A total of 120 participants aged 9-18 years meeting diagnostic criteria for VS will be recruited from the Anglia Ruskin University Eye Clinic. A widely used instrument, the Intuitive Colorimeter, will be used to select, for each participant, the chromaticity of precision tinted lenses (PTL) that they claim optimally alleviates their symptoms and a similar control colour will also be determined. Participants will be randomised into group 1, receiving spectacles with intervention A (optimal tint) followed by B (sub-optimal tint), or group 2, receiving the two interventions in the order BA. The first intervention will be used for 1 month, followed by a 1-month washout period, the second intervention for 1 month, and then a head-to-head comparison in the clinic with participants invited to keep their preferred pair of spectacles. The primary outcome measurement is symptoms (measured by symptom diaries and symptom questionnaires); the secondary outcome measure is observed school performance (measured by academic behaviour surveys); and the tertiary outcome measure will be reading speed (measured by the WRRT).
DISCUSSION: Reviews on VS have reached contradictory conclusions, noting the need for stronger evidence. This trial will be the first in children to use modern diagnostic criteria and will strengthen the evidence base concerning the widespread but still controversial use of coloured filters for children with VS who struggle to read.
TRIAL REGISTRATION: Prospectively registered to clinicaltrials.gov on 17th October 2023 with a unique protocol ID of ETH2223-7100.
METHODS: A total of 120 participants aged 9-18 years meeting diagnostic criteria for VS will be recruited from the Anglia Ruskin University Eye Clinic. A widely used instrument, the Intuitive Colorimeter, will be used to select, for each participant, the chromaticity of precision tinted lenses (PTL) that they claim optimally alleviates their symptoms and a similar control colour will also be determined. Participants will be randomised into group 1, receiving spectacles with intervention A (optimal tint) followed by B (sub-optimal tint), or group 2, receiving the two interventions in the order BA. The first intervention will be used for 1 month, followed by a 1-month washout period, the second intervention for 1 month, and then a head-to-head comparison in the clinic with participants invited to keep their preferred pair of spectacles. The primary outcome measurement is symptoms (measured by symptom diaries and symptom questionnaires); the secondary outcome measure is observed school performance (measured by academic behaviour surveys); and the tertiary outcome measure will be reading speed (measured by the WRRT).
DISCUSSION: Reviews on VS have reached contradictory conclusions, noting the need for stronger evidence. This trial will be the first in children to use modern diagnostic criteria and will strengthen the evidence base concerning the widespread but still controversial use of coloured filters for children with VS who struggle to read.
TRIAL REGISTRATION: Prospectively registered to clinicaltrials.gov on 17th October 2023 with a unique protocol ID of ETH2223-7100.