NCT06093516

The ARUTIS Study (Anglia Ruskin University Trial of the Intuitive System)

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Anglia Ruskin University · Academic / Other
• Sex: All
• Age: 9 Years – 18 Years
• Healthy volunteers: Accepted

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 Precision Tinted Lenses compared to sub-optimal Precision Tinted Lenses (PTLs). In participants ages 9-18 years. Participants, parents and researchers will be masked until the end of the trial. Participants will be randomised into two groups A and B. 50% of participants will receive the optimal PTL where the other 50% will receive the sub-optimal PTL. Participants will be asked to wear the PTLs for one month. Followed by one month of no wear. After which, participants will receive the second pair of PTLs to wear for one month. Participants will need to fill out a symptom dairy everyday from the day of recruitment until the end of the trial. A symptom questionnaire will need to be filled out as baseline at recruitment and the end of each month of wear. An academic behaviour survey will also need to be filled out at baseline by parents and teachers at recruitment and the end of each month of wear. At the end of the three months unmasking will occur and participants will be given the PTL that demonstrate the greatest reduction in VS.

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 changes in behaviour / academic performance, when wearing optimal Precision Tinted Lenses compared to sub-optimal Precision Tinted Lenses (PTL). The PTLs will be prescribed by the Intuitive System. A total of 120 participants aged 9-18 years with symptoms of VS will be recruited from the Anglia Ruskin University eye clinic. Participants will be randomised into either Group 1 (receiving the two interventions A (optimal tint) and B (sub-optimal) in the order AB) or Group 2 (receiving the two interventions in the order BA). The initial pair of PTLs will be given to participants for a one-month wearing period. Subsequently, a one-month washout period is observed, after which participants receive the second pair of PTLs for one-month. Participants are required to fill out a symptom diary daily. A symptom questionnaire will need to be filled out as baseline at recruitment and the end of each month of wear. An academic behaviour survey will also need to be filled out at baseline by parents and teachers at recruitment and the end of each month of wear. Following the three months, a head-to-head comparison and unmasking will occur. Participants will be given the Precision Tinted Lenses that demonstrate the greatest reduction in VS. The study will combine quantitative and qualitative data collection. The primary outcome measure is comparing symptom scores with questionnaires and symptom diaries reported under two different treatment conditions. The secondary outcome measures will be evaluated. in two ways: change in reading speed and results from academic behaviour surveys.

Conditions

• Visual Stress

Interventions

Type	Name	Description
DEVICE	Tinted Lenses	Tinted coloured lenses with UV protection within spectacle frames with the intension to help reduce the symptoms of Visual stress.

Timeline

• Start date: 2023-10-30
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2023-10-23
• Last updated: 2023-10-23

Locations

1 site across 1 country: United Kingdom