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

NCT06093516 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-10-23

No results posted yet for this study

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.

Conditions

  • Visual Stress

Interventions

DEVICE

Tinted Lenses

Tinted coloured lenses with UV protection within spectacle frames with the intension to help reduce the symptoms of Visual stress.

Sponsors & Collaborators

  • Anglia Ruskin University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
9 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2024-09-01
Completion
2024-09-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06093516 on ClinicalTrials.gov