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CL: Performance of Red Tinted Contact Lenses on Colour Defects

Sponsor
National University of Malaysia (Other)
Overall Status
Completed
CT.gov ID
NCT05643222
Collaborator
(none)
6
Enrollment
1
Location
4
Arms
9.3
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: red tint contact lenses
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
6 colour defect subjects eye were inserted with 4 different types of red tinted contact lenses at different times and then tested with Ishihara Test and 100 Hue Test to obtain the score values. This was done only on one non dominant eye of subject.6 colour defect subjects eye were inserted with 4 different types of red tinted contact lenses at different times and then tested with Ishihara Test and 100 Hue Test to obtain the score values. This was done only on one non dominant eye of subject.
Masking:
Single (Outcomes Assessor)
Masking Description:
Only the principal investigator knows the identity of each of the lenses.
Primary Purpose:
Device Feasibility
Official Title:
The Performance of Red Tinted Contact Lenses of Various Tones on Colour Deficient Subjects: A Pilot Study
Actual Study Start Date :
Oct 20, 2020
Actual Primary Completion Date :
Apr 30, 2021
Actual Study Completion Date :
Jul 31, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Optometry Clinic Kuala Lumpur Malaysia 50300

    Sponsors and Collaborators

    • National University of Malaysia

    Investigators

    • Principal Investigator: Haliza Abdul Mutalib, PhD, UKM

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    National University of Malaysia
    ClinicalTrials.gov Identifier:
    NCT05643222
    Other Study ID Numbers:
    • UKM PPI/111/8/JEP-2021-145
    First Posted:
    Dec 8, 2022
    Last Update Posted:
    Dec 8, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by National University of Malaysia
    Anomalous Trichromats
    Color Vision Defect
    Contact Lenses
    Additional relevant MeSH terms:
    Blindness
    Color Vision Defects

    Study Results

    No Results Posted as of Dec 8, 2022