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Impact of Color Correcting Lenses on Color Vision Deficiency

Primary Purpose

Color Blindness, Color Vision Defects, Color Blindness, Green

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental Group 1: Color Correcting Lenses
Placebo Group 1: Placebo Lenses
Placebo Group 1 Crosses over to become Experimental Group 2: Color Correcting Lenses
Experimental Group 1 Crosses over to become Placebo Group 2: Placebo Lenses
Color Correcting Lenses in Subjects with Normal Color Vision
Sponsored by
University of the Incarnate Word
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Color Blindness focused on measuring Color-Correcting Lenses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • no reported history of eye, systemic or ocular disease
  • VA of 20/30 in each eye
  • hereditary color vision deficient (CVDs) verified by failing scores on the red-green anomaloscope (outside system normal range) and Ishihara testing (3 or more errors on 14 testable plates)
  • color vision normal (CVNs) verified by passing red-green anomaloscope (outside system normal range) and Ishihara testing (3 or more errors on 14 testable plates)

Exclusion Criteria:

  • reported use of sleep-inducing or wakefulness drugs

Sites / Locations

  • University of the Incarnate Word Rosenberg School of OptometryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Active Comparator

Arm Label

Color Vision Deficient with Color Correcting Lenses

Color Vision Deficient with Placebo Lenses

Crossover: Placebo to Experimental

Crossover: Experimental to Placebo

Control Group: Subjects with Normal Color Vision

Arm Description

10 subjects confirmed to have hereditary color vision deficiency randomly assigned to experimental group 1 which includes baseline testing with and without color correcting lenses, followed by 7 days of wear, minimum 3 hours/day, followed by retesting with and without color correcting lenses.

10 subjects confirmed to have hereditary color vision deficiency randomly assigned to Placebo Group 1 which includes baseline testing with and without placebo lenses, followed by 7 days of wear, minimum 3 hours/day, followed by retesting with and without placebo lenses.

Placebo Group 1 crosses over to become Experimental Group 2 which includes baseline testing with and without color correcting lenses, followed by 7 days of wear, minimum 3 hours/day, followed by retesting with and without color correcting lenses.

Experimental Group 1 crosses over to become Placebo Group 2 which includes baseline testing with and without placebo lenses, followed by 7 days of wear, minimum 3 hours/day, followed by retesting with and without placebo lenses.

Fifteen subjects confirmed to have normal color vision will be tested in a single session to determine whether color correcting lenses affect color vision in color vision normal subjects and to provided normative data for several unique measures of color vision performance

Outcomes

Primary Outcome Measures

Cone Contrast Test
Cone Contrast Sensitivity (CS) Test (CCT, Innova Systems, Inc.): red, green & blue cone CS using 100-point scale based on log changes in CS. Values will be converted to Z-scores to compare to outcomes with other units.
Cone Contrast Naming Test
Red, green & blue cone CS and color naming accuracy each based on 100-point scale. Values will be converted to Z-scores to compare to outcomes with other units.
Letter Chart Testing
Letter chart cone specific VA, small letter CS, and large letter CS scored as number of letters correct with VA expressed as log MAR & CS as log CS. Values will be converted to Z-scores to compare to outcomes with other units.
Color Matching
Cone specific color matching provides the contrast seen by the normal cone type which matches the contrast seen by the defective cone type in units of % Weber contrast. Values will be converted to Z-scores to compare to outcomes with other units.
Color Identification Test
Cockpit color identification test measure reaction time in seconds and error rate to identify colored targets on a computer display. Values will be converted to Z-scores to compare to outcomes with other units.
Visual Electrodiagnostic Testing
Cone specific visual brainwaves (VEPs) and flash and pattern eye waves (ERGs) will be quantified in terms of amplitude in microvolts and latency in msec. Values will be converted to Z-scores to compare to outcomes with other units.

Secondary Outcome Measures

Full Information

First Posted
July 3, 2022
Last Updated
July 28, 2022
Sponsor
University of the Incarnate Word
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT05463016
Brief Title
Impact of Color Correcting Lenses on Color Vision Deficiency
Official Title
Immediate and Extended Wear Impact of Color Correcting Lenses on Color Vision Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Incarnate Word
Collaborators
National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
To demonstrate improved color vision in subjects with color vision deficiencies while wearing color-correcting lenses and after color-correcting lense use.
Detailed Description
The long term objective of this study is to extend upon research demonstrating improvements in color vision deficiencies (CVDs) while wearing color-correcting lenses (CCLs) and after wearing CCLs. Recordings of brainwaves and eye-waves will be made to assess the retina, optic nerve and brain in order to localize where adaptive changes in the visual system are occurring in response to wearing CCLs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Color Blindness, Color Vision Defects, Color Blindness, Green, Color Blindness, Red
Keywords
Color-Correcting Lenses

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Double blind randomized crossover trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Color Vision Deficient with Color Correcting Lenses
Arm Type
Experimental
Arm Description
10 subjects confirmed to have hereditary color vision deficiency randomly assigned to experimental group 1 which includes baseline testing with and without color correcting lenses, followed by 7 days of wear, minimum 3 hours/day, followed by retesting with and without color correcting lenses.
Arm Title
Color Vision Deficient with Placebo Lenses
Arm Type
Placebo Comparator
Arm Description
10 subjects confirmed to have hereditary color vision deficiency randomly assigned to Placebo Group 1 which includes baseline testing with and without placebo lenses, followed by 7 days of wear, minimum 3 hours/day, followed by retesting with and without placebo lenses.
Arm Title
Crossover: Placebo to Experimental
Arm Type
Experimental
Arm Description
Placebo Group 1 crosses over to become Experimental Group 2 which includes baseline testing with and without color correcting lenses, followed by 7 days of wear, minimum 3 hours/day, followed by retesting with and without color correcting lenses.
Arm Title
Crossover: Experimental to Placebo
Arm Type
Placebo Comparator
Arm Description
Experimental Group 1 crosses over to become Placebo Group 2 which includes baseline testing with and without placebo lenses, followed by 7 days of wear, minimum 3 hours/day, followed by retesting with and without placebo lenses.
Arm Title
Control Group: Subjects with Normal Color Vision
Arm Type
Active Comparator
Arm Description
Fifteen subjects confirmed to have normal color vision will be tested in a single session to determine whether color correcting lenses affect color vision in color vision normal subjects and to provided normative data for several unique measures of color vision performance
Intervention Type
Device
Intervention Name(s)
Experimental Group 1: Color Correcting Lenses
Intervention Description
Color Correcting Lenses
Intervention Type
Device
Intervention Name(s)
Placebo Group 1: Placebo Lenses
Intervention Description
Placebo Lenses
Intervention Type
Device
Intervention Name(s)
Placebo Group 1 Crosses over to become Experimental Group 2: Color Correcting Lenses
Intervention Description
Color Correcting Lenses
Intervention Type
Device
Intervention Name(s)
Experimental Group 1 Crosses over to become Placebo Group 2: Placebo Lenses
Intervention Description
Placebo Lenses
Intervention Type
Device
Intervention Name(s)
Color Correcting Lenses in Subjects with Normal Color Vision
Intervention Description
Color Correcting Lenses
Primary Outcome Measure Information:
Title
Cone Contrast Test
Description
Cone Contrast Sensitivity (CS) Test (CCT, Innova Systems, Inc.): red, green & blue cone CS using 100-point scale based on log changes in CS. Values will be converted to Z-scores to compare to outcomes with other units.
Time Frame
2 WeekS
Title
Cone Contrast Naming Test
Description
Red, green & blue cone CS and color naming accuracy each based on 100-point scale. Values will be converted to Z-scores to compare to outcomes with other units.
Time Frame
2 Weeks
Title
Letter Chart Testing
Description
Letter chart cone specific VA, small letter CS, and large letter CS scored as number of letters correct with VA expressed as log MAR & CS as log CS. Values will be converted to Z-scores to compare to outcomes with other units.
Time Frame
2 Weeks
Title
Color Matching
Description
Cone specific color matching provides the contrast seen by the normal cone type which matches the contrast seen by the defective cone type in units of % Weber contrast. Values will be converted to Z-scores to compare to outcomes with other units.
Time Frame
2 Weeks
Title
Color Identification Test
Description
Cockpit color identification test measure reaction time in seconds and error rate to identify colored targets on a computer display. Values will be converted to Z-scores to compare to outcomes with other units.
Time Frame
2 Weeks
Title
Visual Electrodiagnostic Testing
Description
Cone specific visual brainwaves (VEPs) and flash and pattern eye waves (ERGs) will be quantified in terms of amplitude in microvolts and latency in msec. Values will be converted to Z-scores to compare to outcomes with other units.
Time Frame
2 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: no reported history of eye, systemic or ocular disease VA of 20/30 in each eye hereditary color vision deficient (CVDs) verified by failing scores on the red-green anomaloscope (outside system normal range) and Ishihara testing (3 or more errors on 14 testable plates) color vision normal (CVNs) verified by passing red-green anomaloscope (outside system normal range) and Ishihara testing (3 or more errors on 14 testable plates) Exclusion Criteria: reported use of sleep-inducing or wakefulness drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey C Rabin
Phone
210-883-1197
Email
rabin@uiwtx.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Karoline C Austin
Phone
210-805-3555
Email
koaustin@uiwtx.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Rabin
Organizational Affiliation
C
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of the Incarnate Word Rosenberg School of Optometry
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey C Rabin, OD, PhD
Phone
210-883-1197
Email
rabin@uiwtx.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to share the data with anyone outside the research team.
Citations:
PubMed Identifier
18581942
Citation
Cole BL, Maddocks JD. Color vision testing by Farnsworth lantern and ability to identify approach-path signal colors. Aviat Space Environ Med. 2008 Jun;79(6):585-90. doi: 10.3357/asem.2245.2008.
Results Reference
background
PubMed Identifier
19863590
Citation
Spalding JA, Cole BL, Mir FA. Advice for medical students and practitioners with colour vision deficiency: a website resource. Clin Exp Optom. 2010 Jan;93(1):39-41. doi: 10.1111/j.1444-0938.2009.00434.x. Epub 2009 Oct 27. No abstract available.
Results Reference
background
PubMed Identifier
8977494
Citation
Rabin J. Cone-specific measures of human color vision. Invest Ophthalmol Vis Sci. 1996 Dec;37(13):2771-4.
Results Reference
background
PubMed Identifier
15518234
Citation
Rabin J. Quantification of color vision with cone contrast sensitivity. Vis Neurosci. 2004 May-Jun;21(3):483-5. doi: 10.1017/s0952523804213128.
Results Reference
background
PubMed Identifier
21051721
Citation
Rabin J, Gooch J, Ivan D. Rapid quantification of color vision: the cone contrast test. Invest Ophthalmol Vis Sci. 2011 Feb 9;52(2):816-20. doi: 10.1167/iovs.10-6283.
Results Reference
background
PubMed Identifier
32589909
Citation
Werner JS, Marsh-Armstrong B, Knoblauch K. Adaptive Changes in Color Vision from Long-Term Filter Usage in Anomalous but Not Normal Trichromacy. Curr Biol. 2020 Aug 3;30(15):3011-3015.e4. doi: 10.1016/j.cub.2020.05.054. Epub 2020 Jun 25.
Results Reference
background
PubMed Identifier
27226932
Citation
Rabin JC, Kryder AC, Lam D. Diagnosis of Normal and Abnormal Color Vision with Cone-Specific VEPs. Transl Vis Sci Technol. 2016 May 17;5(3):8. doi: 10.1167/tvst.5.3.8. eCollection 2016 May.
Results Reference
background
PubMed Identifier
28636141
Citation
Rabin J, Kryder A, Lam D. Binocular facilitation of cone-specific visual evoked potentials in colour deficiency. Clin Exp Optom. 2018 Jan;101(1):69-72. doi: 10.1111/cxo.12567. Epub 2017 Jun 21.
Results Reference
background
PubMed Identifier
34999724
Citation
Rabin J, Silva F, Trevino N, Gillentine H, Li L, Inclan L, Anderson G, Lee E, Vo H. Performance enhancement in color deficiency with color-correcting lenses. Eye (Lond). 2022 Jul;36(7):1502-1503. doi: 10.1038/s41433-021-01924-0. Epub 2022 Jan 8. No abstract available.
Results Reference
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Impact of Color Correcting Lenses on Color Vision Deficiency

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