Color Vision DefectsCLNCT05643222
Performance of Red Tinted Contact Lenses on Colour Defects
A study testing red tint contact lenses in people with Color Vision Defects and Color Blindness, run by National University of Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Color Vision Defects, Color Blindness
- What is being tested?
- red tint contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteMalaysia
- Study dates
- 20 Oct 2020to 31 Jul 2021
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range 18-40 years
- all sex
- color defect diagnosed with Ishihara Test
- no contraindication in contact lens wear
Who cannot join
- have ocular and systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Performance of Red Tinted Contact Lenses of Various Tones on Colour Deficient Subjects: A Pilot Study
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.
Read the detailed description
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.
- Conditions
- Color Vision Defects, Color Blindness
- Being tested
- red tint contact lenses
- Keywords
- Anomalous Trichromats, Color Vision Defect, Contact 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.
red tint contact lensesDevice
Also called IGEL Red tint lens type1, IGEL Red tint lens type 2, OCULUS Red tint lens, MAXVUE Red tint lens
to compare the performance of these lenses.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: red tint contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 30 minutes after lens adaptation. Lens is removed immediately after the assessment is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start20 Oct 2020
- Primary completion30 Apr 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Color Vision DefectsStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haliza Abdul Mutalib, PhD, Principal investigator, UKM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643222
- Sponsor's protocol ID
- UKM PPI/111/8/JEP-2021-145
- Acronym
- CL
- Status last verified
- Dec 2022
- First submitted
- 21 Nov 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only the executive summary of all data analysis published by journals will be made available. IPD will be shared only when requested.
Publications
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.
PubMed 17584289
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance of Red Tinted Contact Lenses of Various Tones on Colour Deficient Subjects: A Pilot Study
- ClinicalTrials.gov ID
- NCT05643222
- Acronym / sponsor ID
- CL / UKM PPI/111/8/JEP-2021-145
- Conditions
- Color Vision Defects, Color Blindness
- Keywords
- Anomalous Trichromats, Color Vision Defect, Contact Lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 8 Dec 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.
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
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| TES and performance assessment with Type A Red Tint Lens | Active comparator | Device: red tint contact lenses6 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. |
| TES and performance assessment with Type B Red Tint Lens | Active comparator | Device: red tint contact lenses6 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. |
| TES and performance assessment with Type C Red Tint Lens | Active comparator | Device: red tint contact lenses6 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. |
| TES and performance assessment with Type D Red Tint Lens | Active comparator | Device: red tint contact lenses6 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age range 18-40 years
- all sex
- color defect diagnosed with Ishihara Test
- no contraindication in contact lens wear
Key exclusion criteria (1 listed)
- have ocular and systemic diseases
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 |
|---|---|---|
| red tint contact lensesAlso: IGEL Red tint lens type1, IGEL Red tint lens type 2, OCULUS Red tint lens, MAXVUE Red tint lensto compare the performance of these lenses. | Device | 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 |
Primary outcome
The lens which gives the best result in TES value
Time frame: 30 minutes after lens adaptation. Lens is removed immediately after the assessment is completed.
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
The lens which gives the best performance in ES value
Time frame: 30 minutes after lens adaptation. Lens is removed immediately after the assessment is completed
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
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 8 Dec 2022.
- Background: PubMed 17584289Cole 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.
- Individual participant dataSharing planned: No. 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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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.
Haliza Abdul Mutalib, PhD principal investigator
UKM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing red tint contact lenses in people with Color Vision Defects and Color Blindness, run by National University of Malaysia at 1 site in Malaysia.
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 8 Dec 2022. 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 Malaysia. 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. 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?
The lens which gives the best result in TES value (time frame: 30 minutes after lens adaptation. Lens is removed immediately after the assessment is completed.). The study lists 2 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 NCT05643222, which also lists 1 linked publication.
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 8 Dec 2022.