Color BlindnessNCT05463016

Impact of Color Correcting Lenses on Color Vision Deficiency

A study testing Experimental Group 1: Color Correcting Lenses and Color Correcting Lenses in Subjects with Normal Color Vision in people with Color Blindness and Color Vision Defects, run by University of the Incarnate Word at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To demonstrate improved color vision in subjects with color vision deficiencies while wearing color-correcting lenses and after color-correcting lense use. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Color Blindness, Color Vision Defects, Color Blindness, Green
What is being tested?: Experimental Group 1: Color Correcting Lenses and Color Correcting Lenses in Subjects with Normal Color Vision
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 28 Jul 2022to 31 Mar 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

reported use of sleep-inducing or wakefulness drugs

Trial locations and contacts

1 site in 1 country.

United States1 site

University of the Incarnate Word Rosenberg School of Optometry
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Immediate and Extended Wear Impact of Color Correcting Lenses on Color Vision Deficiency

To demonstrate improved color vision in subjects with color vision deficiencies while wearing color-correcting lenses and after color-correcting lense use.

Read the 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.

Conditions: Color Blindness, Color Vision Defects, Color Blindness, Green, Color Blindness, Red
Being tested: 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
Keywords: Color-Correcting Lenses
Medical subject headings: Color Vision Defects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental Group 1: Color Correcting LensesDevice
Color Correcting Lenses
Placebo Group 1: Placebo LensesDevice
Placebo Lenses
Placebo Group 1 Crosses over to become Experimental Group 2: Color Correcting LensesDevice
Color Correcting Lenses
Experimental Group 1 Crosses over to become Placebo Group 2: Placebo LensesDevice
Placebo Lenses
Color Correcting Lenses in Subjects with Normal Color VisionDevice
Color Correcting Lenses

Study groups in NCT05463016
Study group	Role	What they receive
Color Vision Deficient with Color Correcting Lenses	Experimental	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. Receives: Device: Experimental Group 1: Color Correcting Lenses
Color Vision Deficient with Placebo Lenses	Placebo comparator	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. Receives: Device: Placebo Group 1: Placebo Lenses
Crossover: Placebo to Experimental	Experimental	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. Receives: Device: Placebo Group 1 Crosses over to become Experimental Group 2: Color Correcting Lenses
Crossover: Experimental to Placebo	Placebo comparator	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. Receives: Device: Experimental Group 1 Crosses over to become Placebo Group 2: Placebo Lenses
Control Group: Subjects with Normal Color Vision	Active comparator	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 Receives: Device: Color Correcting Lenses in Subjects with Normal Color Vision

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 WeekS
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.
Measured: 2 Weeks
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.
Measured: 2 Weeks
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.
Measured: 2 Weeks
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.
Measured: 2 Weeks
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.
Measured: 2 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 202231 Mar 2024

First posted18 Jul 2022
Study start28 Jul 2022
Primary completion1 Aug 2023
Study completion31 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Color BlindnessStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Double blind randomized crossover trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05463016
Sponsor's protocol ID: 2022-1194-EXP
Other IDs: 1T35EY032441-01A1
Status last verified: Apr 2024
First submitted: 3 Jul 2022
Last updated: 3 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: There are no plans to share the data with anyone outside the research team.

Publications

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.
PubMed 18581942
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.
PubMed 19863590
Rabin J. Cone-specific measures of human color vision. Invest Ophthalmol Vis Sci. 1996 Dec;37(13):2771-4.
PubMed 8977494
Rabin J. Quantification of color vision with cone contrast sensitivity. Vis Neurosci. 2004 May-Jun;21(3):483-5. doi: 10.1017/s0952523804213128.
PubMed 15518234
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.
PubMed 21051721
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.
PubMed 32589909
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.
PubMed 27226932
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.
PubMed 28636141
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.
PubMed 34999724

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immediate and Extended Wear Impact of Color Correcting Lenses on Color Vision Deficiency
ClinicalTrials.gov ID: NCT05463016
Acronym / sponsor ID: 2022-1194-EXP
Conditions: Color Blindness, Color Vision Defects, Color Blindness, Green, Color Blindness, Red
Keywords: Color-Correcting Lenses
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: University of the Incarnate WordUniversity, hospital or other
Collaborators: National Eye Institute (NEI)
Study start: 28 Jul 2022 (actual)
Primary completion: 1 Aug 2023 (actual)
Study completion: 31 Mar 2024 (actual)
First posted: 18 Jul 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To demonstrate improved color vision in subjects with color vision deficiencies while wearing color-correcting lenses and after color-correcting lense use.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5
Model description: Double blind randomized crossover trial

Arm	Type	Receives
Color Vision Deficient with Color Correcting Lenses	Experimental	Device: Experimental Group 1: Color Correcting Lenses10 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.
Color Vision Deficient with Placebo Lenses	Placebo comparator	Device: Placebo Group 1: Placebo Lenses10 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.
Crossover: Placebo to Experimental	Experimental	Device: Placebo Group 1 Crosses over to become Experimental Group 2: Color Correcting LensesPlacebo 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.
Crossover: Experimental to Placebo	Placebo comparator	Device: Experimental Group 1 Crosses over to become Placebo Group 2: Placebo LensesExperimental 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.
Control Group: Subjects with Normal Color Vision	Active comparator	Device: Color Correcting Lenses in Subjects with Normal Color VisionFifteen 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (1 listed)

reported use of sleep-inducing or wakefulness drugs

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Experimental Group 1: Color Correcting LensesColor Correcting Lenses	Device	Color Vision Deficient with Color Correcting Lenses
Placebo Group 1: Placebo LensesPlacebo Lenses	Device	Color Vision Deficient with Placebo Lenses
Placebo Group 1 Crosses over to become Experimental Group 2: Color Correcting LensesColor Correcting Lenses	Device	Crossover: Placebo to Experimental
Experimental Group 1 Crosses over to become Placebo Group 2: Placebo LensesPlacebo Lenses	Device	Crossover: Experimental to Placebo
Color Correcting Lenses in Subjects with Normal Color VisionColor Correcting Lenses	Device	Control Group: Subjects with Normal Color Vision

Primary outcome

Cone Contrast Test
Time frame: 2 WeekS
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
Time frame: 2 Weeks
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
Time frame: 2 Weeks
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
Time frame: 2 Weeks
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
Time frame: 2 Weeks
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
Time frame: 2 Weeks
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
Background: PubMed 18581942Cole 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.
Background: PubMed 19863590Spalding 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.
Background: PubMed 8977494Rabin J. Cone-specific measures of human color vision. Invest Ophthalmol Vis Sci. 1996 Dec;37(13):2771-4.
Background: PubMed 15518234Rabin J. Quantification of color vision with cone contrast sensitivity. Vis Neurosci. 2004 May-Jun;21(3):483-5. doi: 10.1017/s0952523804213128.
Background: PubMed 21051721Rabin 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.
Background: PubMed 32589909Werner 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.
Background: PubMed 27226932Rabin 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.
Background: PubMed 28636141Rabin 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.
Background: PubMed 34999724Rabin 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.
Individual participant dataSharing planned: No. There are no plans to share the data with anyone outside the research team.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffrey Rabin principal investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cone Contrast Test (time frame: 2 WeekS). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05463016, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.