Vision DisordersNCT02680223
Efficacy of Coloured Overlays and Lenses for Reading Difficulty
A study testing Precision tinted lenses and Non-beneficial tinted lenses in people with Vision Disorders and Reading Disabilities, run by City, University of London at 1 site in United Kingdom.
Trial summary
This is a randomised controlled trial with the aim of testing the efficacy of coloured overlays and coloured lenses for the relief of visual stress and reading difficulties in children and young adults. Read more about this study
- Who is it for?
- Ages 8 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Vision Disorders, Reading Disabilities
- What is being tested?
- Precision tinted lenses and Non-beneficial tinted lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Dec 2019
- 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 8 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals with visual stress or reading disability aged 8 years and over.
Who cannot join
- Ocular or systemic disease
- Intellectual disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Coloured Overlays and Lenses for Adults With Reading Difficulty
This is a randomised controlled trial with the aim of testing the efficacy of coloured overlays and coloured lenses for the relief of visual stress and reading difficulties in children and young adults.
Read the detailed description
Participants will be adults aged from 8 years, with symptoms of visual stress (discomfort when reading or experiencing perceptual symptoms when reading such as letters moving or distorted) or with a diagnosed reading difficulty (dyslexia). Participants will be recruited from the City University London optometry clinic and the City University London Learning Success unit. Participants within this age range and with visual stress will be eligible to participate. Potential participants with an ocular or systemic condition with possible impact on vision (e.g. amblyopia or diabetes respectively) or with intellectual disability will be excluded from the study. Each potential participant will undergo an eye examination prior to participation, during which the following tests will be conducted:
Prior to study entry:
History and symptoms Direct ophthalmoscopy (to check for ocular abnormality) Retinoscopy and subjective refraction (to quantify corrected and uncorrected refractive error) Cover tests (to look for any eye misalignment)
Baseline tests on study entry:
Each eligible participant who agrees to take part in the study will undergo testing with coloured overlays, to determine whether a particular overlay appears to be beneficial in terms of reducing difficulty or discomfort while reading. If so, the participant will be provided with the overlay to use for a period of two weeks, to determine whether it is consistently beneficial when reading during that period. In addition, the Wilkins Rate of Reading Test (WRRT) will be carried out at this baseline stage with and without the overlay.
Follow-up test 1:
The participant will attend a further appointment at the two week time point, and if the overlay was beneficial, an addition test will be carried out using the Intuitive Colorimeter, to determine the exact hue, saturation and intensity of coloured lenses that offer the most relief from difficulty or discomfort while reading. Once this colour has been determined, the hue will be modified to find the closest colour at which the participant first loses benefit (the point at which the discomfort or difficulty returns). Each colour setting (beneficial and non-beneficial) will be noted and the participant will be provided with spectacle lenses tinted exactly to one of these colour specifications. In a crossover design, the order in which true or control lenses will be provided to each participant will be determined by random number generation. Allocation will be carried out by personnel who are not researchers on this study, and who know the order (true lens tint first or second) as 1 and 2. Ordering of tinted spectacles will be handled by the personnel who are not researchers on the study, and this information will not be accessible by the researchers. Thus, tinted lens ordering will not be shared with the researchers, who will not know whether each participant is wearing the beneficial or non-beneficial tint, and so will be masked. Similarly, participants will be unaware whether they are wearing the true or control tint, at any time during their participation. The non-beneficial tint will be very similar to the beneficial tint, so neither researchers nor participants will be able to determine this. On this occasion the participant will also be asked to describe the difficulties he/she has experiences when reading with and without the coloured overlay.
Follow-up test 2:
After one month wearing the first pair of tinted lenses, reading speed will be measured again with the first pair of tinted lenses, and the participant will be asked again about their experience of reading difficulties while wearing these glasses. The participant will be asked to spend one week without any tinted lenses, and to return for a further visit after that week. After this period, the second pair of tinted lenses will be provided, to be worn for a further month.
Follow-up test 3:
Reading speed will be measured again with the second pair of tinted lenses and the participant will again be asked about their experience of reading difficulties while wearing these glasses.
Statistical analysis The main outcome measures are rates of reading provided by the two reading tests, with the two tinted lens types, the overlay, and without any tint. These are quantitative tests and the results will be compared between the two groups using an unpaired t-test, and within individuals (between baseline and follow-up tests) using a repeated measures analysis of variance. In addition, qualitative data are obtained from participants' descriptions of their experience of reading difficulty at different stages of the study. These responses will be analysed using NVivo software to look for themes.
- Conditions
- Vision Disorders, Reading Disabilities
- Being tested
- Precision tinted lenses, Non-beneficial tinted lenses
- Medical subject headings
- Vision Disorders, Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision tinted lensesDevice
Tinted lens for patient with reading difficulty or visual stress
Non-beneficial tinted lensesDevice
Tinted lenses that are unlikely to help reading difficulty or visual stress
| Study group | Role | What they receive |
|---|---|---|
| Precision tinted lenses | Active comparator | Precision tinted lenses will be provided for one month. Receives: Device: Precision tinted lenses |
| Non-beneficial tinted lenses | Sham comparator | Tinted lenses at a colour different from but not easily distinguishable from the precision tinted will be provided for one month. Receives: Device: Non-beneficial tinted lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of reading
Wilkins rate of reading test
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 posted11 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Vision DisordersStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- City, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Suttle, Principal investigator, City, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680223
- Sponsor's protocol ID
- BA_2015
- Status last verified
- Aug 2019
- First submitted
- 2 Feb 2016
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- 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 18565084Bouldoukian J, Wilkins AJ, Evans BJ. Randomised controlled trial of the effect of coloured overlays on the rate of reading of people with specific learning difficulties. Ophthalmic Physiol Opt. 2002 Jan;22(1):55-60. doi: 10.1046/j.1475-1313.2002.00002.x.
PubMed 11829008Monger L, Wilkins A, Allen P. Identifying visual stress during a routine eye examination. J Optom. 2015 Apr-Jun;8(2):140-5. doi: 10.1016/j.optom.2014.10.001. Epub 2014 Nov 11.
PubMed 25455572Allen 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 23586285Wilkins 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 8944196Creavin AL, Lingam R, Steer C, Williams C. Ophthalmic abnormalities and reading impairment. Pediatrics. 2015 Jun;135(6):1057-65. doi: 10.1542/peds.2014-3622.
PubMed 26009619
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Coloured Overlays and Lenses for Adults With Reading Difficulty
- ClinicalTrials.gov ID
- NCT02680223
- Acronym / sponsor ID
- BA_2015
- Conditions
- Vision Disorders, Reading Disabilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- City, University of LondonUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 11 Feb 2016 (estimated)
- 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 randomised controlled trial with the aim of testing the efficacy of coloured overlays and coloured lenses for the relief of visual stress and reading difficulties in children and young adults.
Detailed description
Participants will be adults aged from 8 years, with symptoms of visual stress (discomfort when reading or experiencing perceptual symptoms when reading such as letters moving or distorted) or with a diagnosed reading difficulty (dyslexia). Participants will be recruited from the City University London optometry clinic and the City University London Learning Success unit. Participants within this age range and with visual stress will be eligible to participate. Potential participants with an ocular or systemic condition with possible impact on vision (e.g. amblyopia or diabetes respectively) or with intellectual disability will be excluded from the study. Each potential participant will undergo an eye examination prior to participation, during which the following tests will be conducted:
Prior to study entry:
History and symptoms Direct ophthalmoscopy (to check for ocular abnormality) Retinoscopy and subjective refraction (to quantify corrected and uncorrected refractive error) Cover tests (to look for any eye misalignment)
Baseline tests on study entry:
Each eligible participant who agrees to take part in the study will undergo testing with coloured overlays, to determine whether a particular overlay appears to be beneficial in terms of reducing difficulty or discomfort while reading. If so, the participant will be provided with the overlay to use for a period of two weeks, to determine whether it is consistently beneficial when reading during that period. In addition, the Wilkins Rate of Reading Test (WRRT) will be carried out at this baseline stage with and without the overlay.
Follow-up test 1:
The participant will attend a further appointment at the two week time point, and if the overlay was beneficial, an addition test will be carried out using the Intuitive Colorimeter, to determine the exact hue, saturation and intensity of coloured lenses that offer the most relief from difficulty or discomfort while reading. Once this colour has been determined, the hue will be modified to find the closest colour at which the participant first loses benefit (the point at which the discomfort or difficulty returns). Each colour setting (beneficial and non-beneficial) will be noted and the participant will be provided with spectacle lenses tinted exactly to one of these colour specifications. In a crossover design, the order in which true or control lenses will be provided to each participant will be determined by random number generation. Allocation will be carried out by personnel who are not researchers on this study, and who know the order (true lens tint first or second) as 1 and 2. Ordering of tinted spectacles will be handled by the personnel who are not researchers on the study, and this information will not be accessible by the researchers. Thus, tinted lens ordering will not be shared with the researchers, who will not know whether each participant is wearing the beneficial or non-beneficial tint, and so will be masked. Similarly, participants will be unaware whether they are wearing the true or control tint, at any time during their participation. The non-beneficial tint will be very similar to the beneficial tint, so neither researchers nor participants will be able to determine this. On this occasion the participant will also be asked to describe the difficulties he/she has experiences when reading with and without the coloured overlay.
Follow-up test 2:
After one month wearing the first pair of tinted lenses, reading speed will be measured again with the first pair of tinted lenses, and the participant will be asked again about their experience of reading difficulties while wearing these glasses. The participant will be asked to spend one week without any tinted lenses, and to return for a further visit after that week. After this period, the second pair of tinted lenses will be provided, to be worn for a further month.
Follow-up test 3:
Reading speed will be measured again with the second pair of tinted lenses and the participant will again be asked about their experience of reading difficulties while wearing these glasses.
Statistical analysis The main outcome measures are rates of reading provided by the two reading tests, with the two tinted lens types, the overlay, and without any tint. These are quantitative tests and the results will be compared between the two groups using an unpaired t-test, and within individuals (between baseline and follow-up tests) using a repeated measures analysis of variance. In addition, qualitative data are obtained from participants' descriptions of their experience of reading difficulty at different stages of the study. These responses will be analysed using NVivo software to look for themes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precision tinted lenses | Active comparator | Device: Precision tinted lensesPrecision tinted lenses will be provided for one month. |
| Non-beneficial tinted lenses | Sham comparator | Device: Non-beneficial tinted lensesTinted lenses at a colour different from but not easily distinguishable from the precision tinted will be provided for one month. |
Who may qualify
- Ages
- 8 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with visual stress or reading disability aged 8 years and over.
Key exclusion criteria (2 listed)
- Ocular or systemic disease
- Intellectual disability
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 lensesTinted lens for patient with reading difficulty or visual stress | Device | Precision tinted lenses |
| Non-beneficial tinted lensesTinted lenses that are unlikely to help reading difficulty or visual stress | Device | Non-beneficial tinted lenses |
Primary outcome
Rate of reading
Time frame: 3 months
Wilkins rate of reading test
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 27 Jan 2020.
- 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 11829008Bouldoukian J, Wilkins AJ, Evans BJ. Randomised controlled trial of the effect of coloured overlays on the rate of reading of people with specific learning difficulties. Ophthalmic Physiol Opt. 2002 Jan;22(1):55-60. doi: 10.1046/j.1475-1313.2002.00002.x.
- Background: PubMed 25455572Monger L, Wilkins A, Allen P. Identifying visual stress during a routine eye examination. J Optom. 2015 Apr-Jun;8(2):140-5. doi: 10.1016/j.optom.2014.10.001. Epub 2014 Nov 11.
- 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 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 26009619Creavin AL, Lingam R, Steer C, Williams C. Ophthalmic abnormalities and reading impairment. Pediatrics. 2015 Jun;135(6):1057-65. doi: 10.1542/peds.2014-3622.
- 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.
Catherine Suttle principal investigator
City, University of London
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 lenses and Non-beneficial tinted lenses in people with Vision Disorders and Reading Disabilities, run by City, University of London 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 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: finished, as of the sponsor's last update on 27 Jan 2020. 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?
Rate of reading (time frame: 3 months). 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 NCT02680223, which also lists 7 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 27 Jan 2020.