Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06093516
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-10-17
Brief Title:
The ARUTIS Study Anglia Ruskin University Trial of the Intuitive System
Sponsor:
Anglia Ruskin University
Organization:
Anglia Ruskin University
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARUTIS
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
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 ABBA 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None