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Clinical Trials/NCT02680223
NCT02680223CompletedNot Applicable

Efficacy of Coloured Overlays and Lenses for Adults With Reading Difficulty

City, University of London1 site in 1 country40 target enrollmentStarted: January 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Rate of reading

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
8 Years to 100 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •Ocular or systemic disease
  • •Intellectual disability

Arms & Interventions

Precision tinted lenses

Active Comparator

Precision tinted lenses will be provided for one month.

Intervention: Precision tinted lenses (Device)

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.

Intervention: Non-beneficial tinted lenses (Device)

Outcomes

Primary Outcomes

Rate of reading

Time Frame: 3 months

Wilkins rate of reading test

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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