Reading; Through the Eyes of a University Student

Study Overview
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Brief Summary
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This is a double-masked randomized controlled trial which aims to assess the effects of precision tinted spectacle lenses on visual stress symptoms within an undergraduate University student population.

Detailed Description
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The participants will be recruited from the undergraduate Ulster University student population. Those students who have been identified as potentially having visual stress will be invited to undergo screening tests to assess their eligibility to participate in the randomized controlled trial. Visit 1: Each consenting participant will undergo tests to assess their eligibility to participate in this study. Provided the participant meets the inclusion criteria then they will undergo a baseline eye examination and reading tests including the Wilkins Rate of Reading test (WRRT). The participant will then undergo colorimetry testing using the Intuitive colorimeter (Cerium TM) using the established procedure to individually measure the optimum chromaticity which alleviates visual stress symptoms for each participant. This will be the 'experimental' colour. A second colour will be measured at which visual stress symptoms will be present, this colour will not be aversive to the participant and will be as close to the 'experimental' colour as possible to aid masking. This will be the 'control' colour and it will be individually determined for each participant. Participants and researchers will be masked to which spectacles are 'control' and 'experimental' throughout the course of the trial. Visit 2 & 3: The participant will be invited to return to collect one pair of spectacle with coloured lenses. Reading speed will be assessed using the Wilkins Rate of Reading Test (WRRT) and visual stress will be assessed using a symptom questionnaire and Pattern Glare Test (PGT) with and without the coloured spectacles. The participant will be asked to take the spectacles away and will be advised to wear the spectacles for concentrated tasks, including reading. The participant is free to choose when they wish to wear the spectacles. The participant will keep the spectacles for a minimum of ten weeks, after this time they will be invited to return the spectacles and repeat measures of reading speed and visual stress will be assessed. Participants will be asked to document reading symptoms in an online diary and note the length of spectacle wear-time at the start and end of the 10-week wear period. There will be a time lapse between visit 3 and visit 4 where the participant will have no coloured spectacles. Visit 4 & 5 The participant will return to collect the other pair of spectacles. Reading speed and visual stress will be assessed as in visit 2 & 3. They will keep the spectacles for the same time period. They will be invited to return, at the end of visit 5 the participant will be able to chose their preferred pair of coloured spectacles to take away with them to keep. Four months later the participant will be contacted to check if they are still wearing the coloured spectacles.

Official Title
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Reading; Through the Eyes of a University Student. A Double-masked, Randomised Control Trial to Assess the Effect of Precision Tinted Spectacle Filters on Visual Stress Symptoms Within the University Student Population

Conditions
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Visual Stress, Meares-Irlen Syndrome, Reading Difficulties

Intervention / Treatment
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* Device: Precision tinted spectacle lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consenting undergraduate University students, studying at Ulster University who have visual stress symptoms. Exclusion Criteria: Reduced visual acuity Uncorrected spectacle prescription Decompensating heterophoria Heterotropia Accommodative insufficiency Convergence insufficiency Ocular health abnormality Any participant currently using precision tinted lenses

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The participant will be given either the 'experimental' coloured spectacle lenses or the 'control' coloured spectacle lenses to wear for a minimum of ten weeks, the spectacles will be returned. A 'washout' period will occur and then the participant will be given the alternative pair of coloured spectacles to wear.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 'Experimental' coloured spectacle lenses<br>Precision tinted lenses available from Cerium Technologies (TM) which will be the optimum chromaticity to alleviate visual stress symptoms. To be worn for a minimum of 10 weeks for concentrated tasks. | Device: Precision tinted spectacle lenses<br>* Precision tinted spectacles lenses (Cerium Technologies TM)<br>|
| Placebo Comparator: 'Control' coloured spectacle lenses<br>Precision tinted lenses available from Cerium Technologies (TM) which will be individually determined as being sub-optimal to alleviate visual stress symptoms. This colour will be as similar to the 'experimental' colour as possible and will not be aversive to the participant. To be worn for a minimum of 10 weeks for concentrated tasks. | Device: Precision tinted spectacle lenses<br>* Precision tinted spectacles lenses (Cerium Technologies TM)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reading rate | Wilkins rate of reading test | 20 weeks | 
| Symptoms | Symptom diary to be completed by the participant daily for the first and final week of wear of each pair of spectacles. The participant will be asked details about how much reading they have performed, how long they have worn the spectacles for and if they have experienced any symptoms of visual perceptual distortions. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voluntary use of coloured spectacles | Unprompted, voluntary use of the 'experimental' coloured spectacles | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visual stress, Meares-Irlen syndrome, reading difficulties