Reading; Through the Eyes of a University Student

NCT04318106 | Completed

• 1 other identifier: FCBMS-19-189
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Reading Difficulties; Visual Stress; Meares-Irlen Syndrome

Keywords

Visual stress; Meares-Irlen syndrome; reading difficulties

Outcome Measures

Primary Outcomes (2)

• Reading rate

  Wilkins rate of reading test

  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.

  12 weeks

Secondary Outcomes (1)

• Voluntary use of coloured spectacles

  3 months

Study Arms (2)

'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.

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.

Device: Precision tinted spectacle lenses

Interventions

Precision tinted spectacle lenses DEVICE

Precision tinted spectacles lenses (Cerium Technologies TM)

'Control' coloured spectacle lenses; 'Experimental' coloured spectacle lenses

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All consenting undergraduate University students, studying at Ulster University who have visual stress symptoms.

You may not qualify if:

• Reduced visual acuity
• Uncorrected spectacle prescription
• Decompensating heterophoria
• Heterotropia
• Accommodative insufficiency
• Convergence insufficiency
• Ocular health abnormality
• Any participant currently using precision tinted lenses

Sponsors & Collaborators

• University of Ulster: lead

Study Sites (1)

Ulster University

Coleraine, Londonderry, BT52 1SA, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 7845693 BACKGROUND

• 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.

  PMID: 18565084 BACKGROUND

• 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.

  PMID: 8944196 BACKGROUND

• 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.

  PMID: 23586285 BACKGROUND

• 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.

  PMID: 17557688 BACKGROUND

• 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.

  PMID: 12477018 BACKGROUND

• 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.

  PMID: 27890547 BACKGROUND

• 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.

  PMID: 27580753 BACKGROUND

• 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.

  PMID: 15854076 BACKGROUND

• 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.

  PMID: 40587476 DERIVED

Study Officials

• Sara McCullough, PhD

  Ulster University

  PRINCIPAL INVESTIGATOR

• Julie-Anne Little, PhD

  Ulster University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 23, 2020
• Study Start: January 27, 2020
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)