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NCT06093516: ARUTIS

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

Status unknown NA Last updated 23 October 2023
What this trial tests

NA trial testing Tinted Lenses in Visual Stress in 120 participants. Status unknown.

Timeline
30 October 2023
Primary endpoint
1 September 2024
1 September 2024

Quick facts

Lead sponsorAnglia Ruskin University
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposetreatment
Enrollment120
Start date30 October 2023
Primary completion1 September 2024
Estimated completion1 September 2024
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Anglia Ruskin University

Who can join

Adults 9 to 18, any sex, with Visual Stress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. 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.
    Ramsahye ZN, Allen PM, Thomas NJ, Wilkins AJ, et al · · 2025 · PMID 41402843 · DOI 10.1186/s13063-025-09305-8

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06093516.

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