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

NCT06093516 | Unknown

• 1 other identifier: ETH2223-7100
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Visual stress; Intuitive system; Intuitive colorimeter; Colorimetry; Precision Tinted Lenses; Wilkins Rate of Reading test

Outcome Measures

Primary Outcomes (2)

• Comparing symptom scores with symptom diaries reported under the two different treatment conditions

  Participants will be requiured to fill out a daily diary from day of recruitment to the end of the trial.

  3 months

• Comparing symptom scores with questionnaires reported under the two different treatment conditions.

  Participants will be required to fill out symptom questionnaires at baseline and at the end of each month wear.

  3 months

Secondary Outcomes (2)

• Identify the change in reading speed for participants (if any) when wearing PTLs, by analysing the results of the Wilkins Rate of Reading test (WRRT).

  3 months

• Identify the academic/behavioural change (if any) in participants when wearing PTLs, by analysing a survey completed by parents/guardians and teachers.

  3 months

Study Arms (2)

Optimal Precision Tinted Lenses (PTL)

EXPERIMENTAL

1. The participant is asked to describe any perceptual distortion and discomfort of the text in the colorimeter. 2. At each of the 12 hues in turn the saturation of colour is increased from white to modest saturation (30) and after 5s returned to white. The participant is asked to compare the coloured text with the white and report any differences in the distortion/discomfort. 3. At the best of the 12 hues, the participant adjusts the saturation to optimise the clarity and comfort of the text (comfort is more important than clarity). 4. At this saturation, the hue is adjusted by small amounts and re-optimised. The saturation is then minimised. 5. At the re-optimised hue/saturation, the brightness is reduced to assess its effects on comfort. If the lower brightness is preferred the saturation is increased slightly to see if the high brightness is better tolerated.

Device: Tinted Lenses

Sub-Optimal Precision Tinted Lenses (PTL)

EXPERIMENTAL

The sub-optimal colour will be chosen as a colour of similar saturation to the optimal colour but differing in u'v' colour space by 0.07. Two colours of equal radial distance from the optimal colour will be considered. The colour that shares the name of the optimal colour or appears most similar will be chosen. After colorimetry, participants will choose a spectacle frame. Two pairs of PTLs will be made up by the manufacturing opticians, one to the optimal colour and the other to a slightly sub-optimal colour.

Device: Tinted Lenses

Interventions

Tinted Lenses DEVICE

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

Optimal Precision Tinted Lenses (PTL); Sub-Optimal Precision Tinted Lenses (PTL)

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 9-18y.
• Meet diagnostic indicators for visual stress (see below)
• Consent (parent and participant to attend for optometric testing and participate in research.
• 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:
• Words Move
• Words Merge
• Patterns or shadows in text (e.g., "rivers")
• Text seems to stand out in 3-D above the page
• Words or letters fade or darken
• Discomfort with certain artificial lights and flicker
• And "At least two of the following three signs from investigations:
• Voluntary unprompted use of an overlay for 3 months or more
• Overlay improves performance at the WWRT BY ≥15%

You may not qualify if:

• History of wearing precision tinted lenses.
• 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

Sponsors & Collaborators

• Anglia Ruskin University: lead

Study Sites (1)

Anglis Ruskin University

Cambridge, RM2 6DH, United Kingdom

RECRUITING

Central Study Contacts

Zahra Ramsahye

CONTACT

07411505276; zk208@pgr.aru.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The ARUTIS study is a double-masked randomised controlled trial (RCT) having a double-masked crossover (AB/BA) design

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: October 30, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after the trial has been completed. Which will be in approximately 12 months. Data will be available for as long as necessary.

Locations

GB (1)