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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TES and performance assessment with Type A Red Tint Lens | Active Comparator | 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. |
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| TES and performance assessment with Type B Red Tint Lens | Active Comparator | 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. |
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| TES and performance assessment with Type C Red Tint Lens | Active Comparator | 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. |
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| TES and performance assessment with Type D Red Tint Lens | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| red tint contact lenses | Device | to compare the performance of these lenses. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haliza Abdul Mutalib, PhD | UKM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optometry Clinic | Kuala Lumpur | 50300 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17584289 | Background | 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. |
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only the executive summary of all data analysis published by journals will be made available. IPD will be shared only when requested.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Informed Consent | Dec 2, 2022 | Dec 1, 2022 | Prot_SAP_ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol: Study Protocol and Statistical Analysis Plan | Dec 2, 2022 | Dec 1, 2022 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003117 | Color Vision Defects |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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.
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Only the principal investigator knows the identity of each of the lenses.
|
| D000077765 |
| Cone Dystrophy |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |