Reading; Through the Eyes of a University Student
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Londonderry
-
Coleraine, Londonderry, United Kingdom, BT52 1SA
- Ulster University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 'Experimental' coloured spectacle lenses
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.
|
Precision tinted spectacles lenses (Cerium Technologies TM)
|
|
Placebo Comparator: 'Control' coloured spectacle lenses
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.
|
Precision tinted spectacles lenses (Cerium Technologies TM)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reading rate
Time Frame: 12 weeks
|
Wilkins rate of reading test
|
12 weeks
|
|
Symptoms
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Voluntary use of coloured spectacles
Time Frame: 3 months
|
Unprompted, voluntary use of the 'experimental' coloured spectacles
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Julie-Anne Little, PhD, Ulster University
- Principal Investigator: Sara McCullough, PhD, Ulster University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Harkin DL, Little JA, McCullough SJ. Reading through the eyes of a university student: A double-masked randomised placebo-controlled cross-over protocol investigating coloured spectacle lens efficacy in adults with visual stress. PLoS One. 2025 Jun 30;20(6):e0309625. doi: 10.1371/journal.pone.0309625. eCollection 2025.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FCBMS-19-189
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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