Efficacy of Coloured Overlays and Lenses for Reading Difficulty

January 24, 2020 updated by: City, University of London

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, EC1V 0HB
        • City University London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals with visual stress or reading disability aged 8 years and over.

Exclusion Criteria:

  • Ocular or systemic disease
  • Intellectual disability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: Precision tinted lenses
Precision tinted lenses will be provided for one month.
Device: Precision tinted lenses
Tinted lens for patient with reading difficulty or visual stress
Sham Comparator: Non-beneficial tinted lenses
Tinted lenses at a colour different from but not easily distinguishable from the precision tinted will be provided for one month.
Device: Non-beneficial tinted lenses
Tinted lenses that are unlikely to help reading difficulty or visual stress

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of reading
Time Frame: 3 months
Wilkins rate of reading test
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City, University of London

Investigators

  • Principal Investigator: Catherine Suttle, City, University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 8, 2016

First Posted (Estimate)

February 11, 2016

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA_2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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