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Reading; Through the Eyes of a University Student

Primary Purpose

Visual Stress, Meares-Irlen Syndrome, Reading Difficulties

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Precision tinted spectacle lenses
Sponsored by
University of Ulster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visual Stress focused on measuring Visual stress, Meares-Irlen syndrome, reading difficulties

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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 with a history of coloured reading aids, (e.g. coloured overlays, coloured spectacle lenses, etc.)

Sites / Locations

  • Ulster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

'Experimental' coloured spectacle lenses

'Control' coloured spectacle lenses

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Reading rate
Wilkins rate of reading test
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.

Secondary Outcome Measures

Voluntary use of coloured spectacles
Unprompted, voluntary use of the 'experimental' coloured spectacles

Full Information

First Posted
March 18, 2020
Last Updated
February 4, 2023
Sponsor
University of Ulster
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1. Study Identification

Unique Protocol Identification Number
NCT04318106
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 27, 2020 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ulster

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 ten 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 10-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. Four months later the participant will be contacted to check if they are still wearing the coloured spectacles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Stress, Meares-Irlen Syndrome, Reading Difficulties
Keywords
Visual stress, Meares-Irlen syndrome, reading difficulties

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigator
Masking Description
The researcher will perform colorimetry testing to measure the chromaticity of the 'experimental' and 'control' coloured lenses.The 'experimental' and 'control' colour will be as similar in chromaticity as possible. The details of the 'experimental' and 'control' colour will be given to an external person who will randomly assign the order in which the spectacles will be collected by the participant. There is a significant time lapse between the colorimetry assessment where the 'experimental' and 'control' colours are measured and the collection of the first pair of spectacles.
Allocation
Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
'Experimental' coloured spectacle lenses
Arm Type
Experimental
Arm Description
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.
Arm Title
'Control' coloured spectacle lenses
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Precision tinted spectacle lenses
Intervention Description
Precision tinted spectacles lenses (Cerium Technologies TM)
Primary Outcome Measure Information:
Title
Reading rate
Description
Wilkins rate of reading test
Time Frame
20 weeks
Title
Symptoms
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Voluntary use of coloured spectacles
Description
Unprompted, voluntary use of the 'experimental' coloured spectacles
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara McCullough, PhD
Organizational Affiliation
Ulster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julie-Anne Little, PhD
Organizational Affiliation
Ulster University
Official's Role
Study Director
Facility Information:
Facility Name
Ulster University
City
Coleraine
State/Province
Londonderry
ZIP/Postal Code
BT52 1SA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
7845693
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.
Results Reference
background
PubMed Identifier
18565084
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.
Results Reference
background
PubMed Identifier
8944196
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.
Results Reference
background
PubMed Identifier
23586285
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.
Results Reference
background
PubMed Identifier
17557688
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.
Results Reference
background
PubMed Identifier
12477018
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.
Results Reference
background
PubMed Identifier
27890547
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.
Results Reference
background
PubMed Identifier
27580753
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.
Results Reference
background
PubMed Identifier
15854076
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.
Results Reference
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Reading; Through the Eyes of a University Student

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