Performance of Red Tinted Contact Lenses on Colour Defects

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Color Vision Defects, Color Blindness

Intervention / Treatment
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* Device: red tint contact lenses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TES and performance assessment with Type A Red Tint Lens<br>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<br>* to compare the performance of these lenses.<br>* Other names: MAXVUE Red tint lens;|
| Active Comparator: TES and performance assessment with Type B Red Tint Lens<br>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<br>* to compare the performance of these lenses.<br>* Other names: MAXVUE Red tint lens;|
| Active Comparator: TES and performance assessment with Type C Red Tint Lens<br>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<br>* to compare the performance of these lenses.<br>* Other names: MAXVUE Red tint lens;|
| Active Comparator: TES and performance assessment with Type D Red Tint Lens<br>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<br>* to compare the performance of these lenses.<br>* Other names: MAXVUE Red tint lens;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anomalous Trichromats, Color Vision Defect, Contact Lenses