Visual StressNCT04318106
Reading; Through the Eyes of a University Student
A study testing Precision tinted spectacle lenses in people with Visual Stress and Meares-Irlen Syndrome, run by University of Ulster at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Stress, Meares-Irlen Syndrome, Reading Difficulties
- What is being tested?
- Precision tinted spectacle lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jan 2020to 30 Jun 2025
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All consenting undergraduate University students, studying at Ulster University who have visual stress symptoms.
Who cannot join
- Reduced visual acuity
- Uncorrected spectacle prescription
- Decompensating heterophoria
- Heterotropia
- Accommodative insufficiency
- Convergence insufficiency
- Ocular health abnormality
- Any participant currently using precision tinted lenses
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ulster University
Coleraine, Londonderry, BT52 1SA
About this study
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
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.
Read the 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.
- Conditions
- Visual Stress, Meares-Irlen Syndrome, Reading Difficulties
- Being tested
- Precision tinted spectacle lenses
- Keywords
- Visual stress, Meares-Irlen syndrome, reading difficulties
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision tinted spectacle lensesDevice
Precision tinted spectacles lenses (Cerium Technologies TM)
| Study group | Role | What they receive |
|---|---|---|
| 'Experimental' coloured spectacle lenses | Experimental | 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. Receives: Device: Precision tinted spectacle lenses |
| 'Control' coloured spectacle lenses | Placebo comparator | 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. Receives: Device: Precision tinted spectacle lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading rate
Wilkins rate of reading test
Measured: 12 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.
Measured: 12 weeks
Secondary outcomes (1)
Voluntary use of coloured spectacles
Unprompted, voluntary use of the 'experimental' coloured spectacles
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 Mar 2020
- Study start27 Jan 2020
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara McCullough, PhD, Principal investigator, Ulster UniversityJulie-Anne Little, PhD, Study director, Ulster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318106
- Sponsor's protocol ID
- FCBMS-19-189
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2020
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 7845693Evans 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.
PubMed 18565084Wilkins 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.
PubMed 8944196Allen 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.
PubMed 23586285Singleton C, Henderson LM. Computerized screening for visual stress in children with dyslexia. Dyslexia. 2007 May;13(2):130-51. doi: 10.1002/dys.329.
PubMed 17557688Evans 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.
PubMed 12477018Evans 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.
PubMed 27890547Griffiths 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.
PubMed 27580753Wilkins 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.
PubMed 15854076Harkin 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.
PubMed 40587476
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04318106
- Acronym / sponsor ID
- FCBMS-19-189
- Conditions
- Visual Stress, Meares-Irlen Syndrome, Reading Difficulties
- Keywords
- Visual stress, Meares-Irlen syndrome, reading difficulties
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 23 Mar 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 'Experimental' coloured spectacle lenses | Experimental | Device: Precision tinted spectacle lensesPrecision 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. |
| 'Control' coloured spectacle lenses | Placebo comparator | Device: Precision tinted spectacle lensesPrecision 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All consenting undergraduate University students, studying at Ulster University who have visual stress symptoms.
Key exclusion criteria (8 listed)
- Reduced visual acuity
- Uncorrected spectacle prescription
- Decompensating heterophoria
- Heterotropia
- Accommodative insufficiency
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 |
|---|---|---|
| Precision tinted spectacle lensesPrecision tinted spectacles lenses (Cerium Technologies TM) | Device | 'Control' coloured spectacle lenses, 'Experimental' coloured spectacle lenses |
Primary outcome
Reading rate
Time frame: 12 weeks
Wilkins rate of reading test
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.
1 secondary outcome
Voluntary use of coloured spectacles
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Background: PubMed 7845693Wilkins 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.
- Background: PubMed 18565084Evans 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.
- Background: PubMed 8944196Wilkins 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.
- Background: PubMed 23586285Allen 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.
- Background: PubMed 17557688Singleton C, Henderson LM. Computerized screening for visual stress in children with dyslexia. Dyslexia. 2007 May;13(2):130-51. doi: 10.1002/dys.329.
- Background: PubMed 12477018Evans 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.
- Background: PubMed 27890547Evans 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.
- Background: PubMed 27580753Griffiths 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.
- Background: PubMed 15854076Wilkins 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.
- Derived from this study: PubMed 40587476Harkin 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.
- Individual participant dataSharing planned: No
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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.
Sara McCullough, PhD principal investigator
Ulster University
Julie-Anne Little, PhD study director
Ulster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision tinted spectacle lenses in people with Visual Stress and Meares-Irlen Syndrome, run by University of Ulster 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 19 Feb 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading rate (time frame: 12 weeks). 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?
On the ClinicalTrials.gov record for NCT04318106, which also lists 10 linked publications.
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 19 Feb 2026.