Performance of Red Tinted Contact Lenses on Colour Defects

NCT05643222 | Completed DMC

• 1 other identifier: UKM PPI/111/8/JEP-2021-145
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Color Vision Defects; Color Blindness

Keywords

Anomalous Trichromats; Color Vision Defect; Contact Lenses

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

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.

Device: red tint contact lenses

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.

Device: red tint contact lenses

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.

Device: red tint contact lenses

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.

Device: red tint contact lenses

Interventions

red tint contact lenses DEVICE

to compare the performance of these lenses.

Also known as: IGEL Red tint lens type1, IGEL Red tint lens type 2, OCULUS Red tint lens, MAXVUE Red tint lens

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age range 18-40 years
• all sex
• color defect diagnosed with Ishihara Test
• no contraindication in contact lens wear

You may not qualify if:

• have ocular and systemic diseases

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Optometry Clinic

Kuala Lumpur, 50300, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 17584289 BACKGROUND

MeSH Terms

Conditions

Color Vision Defects

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Haliza Abdul Mutalib, PhD

  UKM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the principal investigator knows the identity of each of the lenses.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 8, 2022
• Study Start: October 20, 2020
• Primary Completion: April 30, 2021
• Study Completion: July 31, 2021
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)