Visual StressARUTISNCT06093516
The ARUTIS Study (Anglia Ruskin University Trial of the Intuitive System)
A study testing Tinted Lenses in people with Visual Stress, run by Anglia Ruskin University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Stress
- What is being tested?
- Tinted Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
Show all 16Show fewer
- 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%
- PGT result >3 with mid spatial frequency grating.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Anglis Ruskin University
Cambridge, RM2 6DH
Zahra Ramsahye, 07411505276, zk208@pgr.aru.ac.uk
About this study
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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Visual Stress
- Being tested
- Tinted Lenses
- Keywords
- Visual stress, Intuitive system, Intuitive colorimeter, Colorimetry, Precision Tinted Lenses, Wilkins Rate of Reading test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinted LensesDevice
Tinted coloured lenses with UV protection within spectacle frames with the intension to help reduce the symptoms of Visual stress.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Tinted Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start30 Oct 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The ARUTIS study is a double-masked randomised controlled trial (RCT) having a double-masked crossover (AB/BA) design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anglia Ruskin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093516
- Sponsor's protocol ID
- ETH2223-7100
- Acronym
- ARUTIS
- Status last verified
- Sep 2023
- First submitted
- 17 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06093516
- Acronym / sponsor ID
- ARUTIS / ETH2223-7100
- Conditions
- Visual Stress
- Keywords
- Visual stress, Intuitive system, Intuitive colorimeter, Colorimetry, Precision Tinted Lenses, Wilkins Rate of Reading test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Anglia Ruskin UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The ARUTIS study is a double-masked randomised controlled trial (RCT) having a double-masked crossover (AB/BA) design
| Arm | Type | Receives |
|---|---|---|
| Optimal Precision Tinted Lenses (PTL) | Experimental | Device: Tinted Lenses1. 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. |
| Sub-Optimal Precision Tinted Lenses (PTL) | Experimental | Device: Tinted LensesThe 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. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinted LensesTinted coloured lenses with UV protection within spectacle frames with the intension to help reduce the symptoms of Visual stress. | Device | Optimal Precision Tinted Lenses (PTL), Sub-Optimal Precision Tinted Lenses (PTL) |
Primary outcome
Comparing symptom scores with symptom diaries reported under the two different treatment conditions
Time frame: 3 months
Participants will be requiured to fill out a daily diary from day of recruitment to the end of the trial.
Comparing symptom scores with questionnaires reported under the two different treatment conditions.
Time frame: 3 months
Participants will be required to fill out symptom questionnaires at baseline and at the end of each month wear.
2 secondary outcomes
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).
Time frame: 3 months
Identify the academic/behavioural change (if any) in participants when wearing PTLs, by analysing a survey completed by parents/guardians and teachers.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tinted Lenses in people with Visual Stress, run by Anglia Ruskin University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zahra Ramsahye (07411505276, zk208@pgr.aru.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing symptom scores with symptom diaries reported under the two different treatment conditions (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.