Clinical trial NCT04318106: Reading; Through the Eyes of a University Student
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Visual Stress
Meares-Irlen Syndrome
Reading Difficulties
Keywords: Visual stress
Meares-Irlen syndrome
reading difficulties
Lead sponsor: University of Ulster
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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 six 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 6-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.

Three months later the participant will be contacted to check if they are still wearing the coloured spectacles.

Eligibility criteria: 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

Primary outcomes:
measure: Reading rate
timeFrame: 12 weeks
measure: Symptoms
timeFrame: 12 weeks
Secondary outcomes:
measure: Voluntary use of coloured spectacles
timeFrame: 3 months
Other outcomes:
Locations:
city: Coleraine
country: United Kingdom
facility: Ulster University
state: Londonderry
Study officials:
affiliation: Ulster University
name: Sara McCullough, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ulster University
name: Julie-Anne Little, PhD
role: STUDY_DIRECTOR
References:
citation: Wilkins AJ, Evans BJ, Brown JA, Busby AE, Wingfield AE, Jeanes RJ, Bald J. Double-masked placebo-controlled trial of precision spectral filters in children who use coloured overlays. Ophthalmic Physiol Opt. 1994 Oct;14(4):365-70.
citation: Evans BJ, Stevenson SJ. The Pattern Glare Test: a review and determination of normative values. Ophthalmic Physiol Opt. 2008 Jul;28(4):295-309. doi: 10.1111/j.1475-1313.2008.00578.x.
citation: Wilkins AJ, Jeanes RJ, Pumfrey PD, Laskier M. Rate of Reading Test: its reliability, and its validity in the assessment of the effects of coloured overlays. Ophthalmic Physiol Opt. 1996 Nov;16(6):491-7.
citation: Allen PM, Dedi S, Kumar D, Patel T, Aloo M, Wilkins AJ. Accommodation, pattern glare, and coloured overlays. Perception. 2012;41(12):1458-67. doi: 10.1068/p7390.
citation: Singleton C, Henderson LM. Computerized screening for visual stress in children with dyslexia. Dyslexia. 2007 May;13(2):130-51. doi: 10.1002/dys.329.
citation: Evans BJ, Joseph F. The effect of coloured filters on the rate of reading in an adult student population. Ophthalmic Physiol Opt. 2002 Nov;22(6):535-45. doi: 10.1046/j.1475-1313.2002.00071.x.
citation: Evans BJW, Allen PM, Wilkins AJ. A Delphi study to develop practical diagnostic guidelines for visual stress (pattern-related visual stress). J Optom. 2017 Jul-Sep;10(3):161-168. doi: 10.1016/j.optom.2016.08.002. Epub 2016 Nov 24.
citation: Griffiths PG, Taylor RH, Henderson LM, Barrett BT. The effect of coloured overlays and lenses on reading: a systematic review of the literature. Ophthalmic Physiol Opt. 2016 Sep;36(5):519-44. doi: 10.1111/opo.12316.
citation: Wilkins A, Sihra N, Smith IN. How precise do precision tints have to be and how many are necessary? Ophthalmic Physiol Opt. 2005 May;25(3):269-76. doi: 10.1111/j.1475-1313.2005.00279.x.