Performance of Red Tinted Contact Lenses on Colour Defects (CL)

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

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.

Study Overview

• Status: Completed
• Conditions: Color Vision Defects; Color Blindness
• Intervention / Treatment: Device: red tint contact lenses

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 50300
    • Optometry Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TES and performance assessment with Type A Red Tint Lens; 6 subjects will be inserted with the Type A red Tint Lenses. Only the non dominant eye will be inserted. The comparison is made before and after wearing the CL.	Device: red tint contact lenses; 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
Active Comparator: TES and performance assessment with Type B Red Tint Lens; 6 subjects will be inserted with the Type B red Tint Lenses. Only the non dominant eye will be inserted. The comparison is made before and after wearing the CL.	Device: red tint contact lenses; 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
Active Comparator: TES and performance assessment with Type C Red Tint Lens; 6 subjects will be inserted with the Type C red Tint Lenses. Only the non dominant eye will be inserted. The comparison is made before and after wearing the CL.	Device: red tint contact lenses; 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
Active Comparator: TES and performance assessment with Type D Red Tint Lens; 6 subjects will be inserted with the Type D red Tint Lenses. Only the non dominant eye will be inserted. The comparison is made before and after wearing the CL.	Device: red tint contact lenses; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The lens which gives the best result in TES value	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	30 minutes after lens adaptation. Lens is removed immediately after the assessment is completed.
The lens which gives the best performance in ES value	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	30 minutes after lens adaptation. Lens is removed immediately after the assessment is completed

Collaborators and Investigators

• Sponsor: National University of Malaysia
• Investigators: Principal Investigator: Haliza Abdul Mutalib, PhD, UKM

Publications and helpful links

General Publications

• Cole BL, Lian KY, Lakkis C. Using clinical tests of colour vision to predict the ability of colour vision deficient patients to name surface colours. Ophthalmic Physiol Opt. 2007 Jul;27(4):381-8. doi: 10.1111/j.1475-1313.2007.00493.x.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Estimate): December 8, 2022

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Contact Lenses; Anomalous Trichromats; Color Vision Defect
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Eye Diseases, Hereditary; Sensation Disorders; Vision Disorders; Cone Dystrophy; Blindness; Color Vision Defects
• Other Study ID Numbers: UKM PPI/111/8/JEP-2021-145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: only the executive summary of all data analysis published by journals will be made available. IPD will be shared only when requested.

Drug and device information, study documents

• 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