Assessing the impact of tinted lenses on visual stress in children and adolescents
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
This study is testing if special tinted glasses can help kids and teens aged 9-18 with visual stress, reading speed, and school performance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 9 Years to 18 Years |
| Sex | All |
| Sponsor | Anglia Ruskin University Academic / other |
| Locations | 1 site (Cambridge) |
| Trial ID | NCT06093516 on ClinicalTrials.gov |
What this trial studies
The ARUTIS study is a double-masked randomized controlled trial designed to evaluate the effects of optimal versus sub-optimal Precision Tinted Lenses on visual stress symptoms, reading speed, and academic performance in participants aged 9-18 years. A total of 120 participants will be recruited from the Anglia Ruskin University eye clinic and randomly assigned to receive either the optimal or sub-optimal lenses in a crossover design. Each participant will wear the assigned lenses for one month, followed by a washout period, before switching to the other pair for another month. Daily symptom diaries and questionnaires will be utilized to gather data on visual stress and academic behavior throughout the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents aged 9-18 years who exhibit symptoms of visual stress.
Not a fit: Patients with a history of wearing precision tinted lenses or those with ocular or systemic pathologies that may interfere with the study outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective interventions for managing visual stress in children and adolescents, potentially improving their reading abilities and academic performance.
How similar studies have performed: While there have been studies on visual stress and tinted lenses, this specific approach using a double-masked crossover design is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 9-18y. 2. Meet diagnostic indicators for visual stress (see below) 3. Consent (parent and participant to attend for optometric testing and participate in research. 4. 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: 1. Words Move 2. Words Merge 3. Patterns or shadows in text (e.g., "rivers") 4. Text seems to stand out in 3-D above the page 5. Words or letters fade or darken 6. Discomfort with certain artificial lights and flicker And "At least two of the following three signs from investigations: 1. Voluntary unprompted use of an overlay for 3 months or more 2. Overlay improves performance at the WWRT BY ≥15% 3. PGT result \>3 with mid spatial frequency grating. Exclusion Criteria: 1. History of wearing precision tinted lenses. 2. 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
Where this trial is running
Cambridge
- Anglis Ruskin University — Cambridge, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Zahra Ramsahye
- Email: zk208@pgr.aru.ac.uk
- Phone: 07411505276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.