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

Primary Purpose

Color Vision Defects, Color Blindness

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
red tint contact lenses
Sponsored by
National University of Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Color Vision Defects focused on measuring Anomalous Trichromats, Color Vision Defect, Contact Lenses

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Optometry Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

TES and performance assessment with Type A Red Tint Lens

TES and performance assessment with Type B Red Tint Lens

TES and performance assessment with Type C Red Tint Lens

TES and performance assessment with Type D Red Tint Lens

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
November 21, 2022
Last Updated
December 1, 2022
Sponsor
National University of Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05643222
Brief Title
Performance of Red Tinted Contact Lenses on Colour Defects
Acronym
CL
Official Title
The Performance of Red Tinted Contact Lenses of Various Tones on Colour Deficient Subjects: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University of Malaysia

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Color Vision Defects, Color Blindness
Keywords
Anomalous Trichromats, Color Vision Defect, Contact Lenses

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Only the principal investigator knows the identity of each of the lenses.
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TES and performance assessment with Type A Red Tint Lens
Arm Type
Active Comparator
Arm Description
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.
Arm Title
TES and performance assessment with Type B Red Tint Lens
Arm Type
Active Comparator
Arm Description
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.
Arm Title
TES and performance assessment with Type C Red Tint Lens
Arm Type
Active Comparator
Arm Description
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.
Arm Title
TES and performance assessment with Type D Red Tint Lens
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
red tint contact lenses
Other Intervention Name(s)
IGEL Red tint lens type1, IGEL Red tint lens type 2, OCULUS Red tint lens, MAXVUE Red tint lens
Intervention Description
to compare the performance of these lenses.
Primary Outcome Measure Information:
Title
The lens which gives the best result in TES value
Description
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
Time Frame
30 minutes after lens adaptation. Lens is removed immediately after the assessment is completed.
Title
The lens which gives the best performance in ES value
Description
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
Time Frame
30 minutes after lens adaptation. Lens is removed immediately after the assessment is completed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haliza Abdul Mutalib, PhD
Organizational Affiliation
UKM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optometry Clinic
City
Kuala Lumpur
ZIP/Postal Code
50300
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
only the executive summary of all data analysis published by journals will be made available. IPD will be shared only when requested.
Citations:
PubMed Identifier
17584289
Citation
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.
Results Reference
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Performance of Red Tinted Contact Lenses on Colour Defects

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