NCT02680223

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 27, 2020

Status Verified

August 1, 2019

Enrollment Period

3.9 years

First QC Date

February 2, 2016

Last Update Submit

January 24, 2020

Conditions

Vision DisordersReading Disabilities

Outcome Measures

Primary Outcomes (1)

  • Rate of reading

    Wilkins rate of reading test

    3 months

Study Arms (2)

Precision tinted lenses

ACTIVE COMPARATOR

Precision tinted lenses will be provided for one month.

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.

Device: Non-beneficial tinted lenses

Interventions

Precision tinted lensesDEVICE

Tinted lens for patient with reading difficulty or visual stress

Precision tinted lenses
Non-beneficial tinted lensesDEVICE

Tinted lenses that are unlikely to help reading difficulty or visual stress

Non-beneficial tinted lenses

Eligibility Criteria

Age8 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Ocular or systemic disease
  • Intellectual disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City University London

London, EC1V 0HB, United Kingdom

Location

Related Publications (7)

  • 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: 7845693BACKGROUND

  • 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: 18565084BACKGROUND

  • Bouldoukian 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.

    PMID: 11829008BACKGROUND

  • Monger 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.

    PMID: 25455572BACKGROUND

  • 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: 23586285BACKGROUND

  • 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: 8944196BACKGROUND

  • Creavin 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.

    PMID: 26009619BACKGROUND

MeSH Terms

Conditions

Vision DisordersDyslexia

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsSpecific Learning DisorderLearning DisabilitiesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Catherine Suttle

    City, University of London

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 11, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 27, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)