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Completed

NCT Number: NCT05643222

Performance of Red Tinted Contact Lenses on Colour Defects

This study aimed to relate and compare the performance of 4 types of red-tinted contact lenses (CL) with the Total Error Score (TES) from the Farnsworth-Munsell 100 Hue test on colour deficient subjects. Only 6 subject with colour vision defect was tested in this study.

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Key information

Conditions

Color Vision Defects Color Blindness Cone Dystrophy Eye Diseases Eye Diseases, Hereditary Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Optometry Clinic

Kuala Lumpur, 50300, Malaysia

About this study

Six congenital CVD subjects were recruited. After colour vision screening using Ishihara plate, the Farnsworth-Munsell 100 Hue test was carried out to determine the type and severity of colour vision deficiency. Four types of red-tinted CL (Type A, B, C and D) were used. The performance of each of these lenses was determined through the comparison of error scores in the Ishihara test before and after wearing tinted contact lens on only the non-dominant eye. Then, the transmittance of each tinted CL was determined using a spectrophotometer. All these lenses were fitted on the subjects in one day where the subjects were given a 30-minute break for each intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age range 18-40 years
  • all sex
  • color defect diagnosed with Ishihara Test
  • no contraindication in contact lens wear

Exclusion criteria

  • have ocular and systemic diseases

Treatment and study plan

red tint contact lenses

Device

to compare the performance of these lenses.

Other names: IGEL Red tint lens type1, IGEL Red tint lens type 2, OCULUS Red tint lens, MAXVUE Red tint lens

Primary outcomes

  1. The lens which gives the best result in TES value

    Time frame: 30 minutes after lens adaptation. Lens is removed immediately after the assessment is completed.

    The highest TES value scored showed higher performance in colour vision. TES is an automated, generated value that calculates the number of tiles placed incorrectly and scales the value for uniform analysis. Average TES scores range from thirty to forty in series tests; while scores exceeding seventy can point to a marker for color blindness. Lower scores are intended to point to significantly increased color vision accuracy, as the TES score is directly correlated to the number of tiles incorrectly identified

  2. The lens which gives the best performance in ES value

    Time frame: 30 minutes after lens adaptation. Lens is removed immediately after the assessment is completed

    The highest score achieved using Ishihara Test indicates the best red tint lens. The current passing score is 12 correct of 14 red/green test plates (not including the demonstration plate). Research has shown that scores below twelve indicate color vision deficiency, and twelve or more correct indicate normal color vision, with 97% sensitivity and 100% specificity

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

The Performance of Red Tinted Contact Lenses of Various Tones on Colour Deficient Subjects: A Pilot Study

Acronym: CL

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2022
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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