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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimal Precision Tinted Lenses (PTL) | Experimental |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tinted Lenses | Device | Tinted coloured lenses with UV protection within spectacle frames with the intension to help reduce the symptoms of Visual stress. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Participants will be required to perform a WRRT at baseline and at the collection of each PTLs. A WRRT will also be performed at the unmasking stage to compare both PTLs. | 3 months |
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Inclusion Criteria:
Diagnostic indicators for visual stress
At least three of the following six typical symptoms:
And "At least two of the following three signs from investigations:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zahra Ramsahye | Contact | 07411505276 | zk208@pgr.aru.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anglis Ruskin University | Recruiting | Cambridge | RM2 6DH | United Kingdom |
The study will conform to the tenets of the Declaration of Helsinki and will be registered in a clinical trials registry. When the analysis is complete, anonymised data will be stored in a publicly accessible data repository. Full informed consent will be obtained from participants and parents/guardians. Ethical approval was granted from the Anglia Ruskin University Faculty Research Ethics Panel (FREP).
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.
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The ARUTIS study is a double-masked randomised controlled trial (RCT) having a double-masked crossover (AB/BA) design
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| Identify the academic/behavioural change (if any) in participants when wearing PTLs, by analysing a survey completed by parents/guardians and teachers. |
Parents/ teachers will be required to fill out the the academic/behavioural survey at baseline and at the end of each month wear. |
| 3 months |