Refractive ErrorsNCT07001124
Comparative Efficacy of Duochrome Test Verse +1 Blur Test in Detecting Refracting Error Across Different Ages
A study testing duochrome test and +1 blur test in people with Refractive Errors, run by Superior University at 1 site in Pakistan.
Trial summary
The comparative efficacy of the duochrome test versus +1 blur test in detecting refractive errors across different ages remains under-explored in current ophthalmic research. While the duochrome test is widely used to refine prescriptions, its standalone effectiveness compared to +1 blur test based refraction has not… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Refractive Errors
- What is being tested?
- duochrome test and +1 blur test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 to 60 years old.
- Both genders.
- Those who have refractive error.
- Patients with no history of prior eye surgery.
- No active eye diseases affecting visual acuity, such as cataracts or retinal disorders.
- Ability to cooperate with both the duochrome test and +1 blur test.
Who cannot join
- Patients with severe visual impairment or neurological conditions affecting vision.
- Patients with nystagmus or conditions that could interfere with reliable testing.
- Age below 18 year and above 60 year excluded
- Those patients who don't show their consent.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Eye professionals clinic (14-S DHA Phase 2 Ghazi road)
Lahore, Punjab Province
About this study
The comparative efficacy of the duochrome test versus +1 blur test in detecting refractive errors across different ages remains under-explored in current ophthalmic research. While the duochrome test is widely used to refine prescriptions, its standalone effectiveness compared to +1 blur test based refraction has not been thoroughly investigated.
Read the detailed description
This study aims to evaluate the efficacy, accuracy, and reliability of the duochrome test in identifying refractive errors, including myopia and hyperopia across various ages. Refractive errors, including myopia, hyperopia, and astigmatism, are leading causes of visual impairment, requiring precise diagnostic tools. The duochrome test utilizes chromatic aberration to refine prescriptions, whereas the +1 blur test assesses spherical correction accuracy. Despite their clinical use, direct comparative studies remain limited. A total of 33 participants with estimated 10% dropout randomly assigned to undergo both tests. Groups will be based on different ages, Group A (18-35 years)and group B (36-60 years) ..both test (Duochrome test and +1 blur test) will apply on every patients.
- Conditions
- Refractive Errors
- Being tested
- duochrome test and +1 blur test
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duochrome test and +1 blur testDiagnostic test
The participant is seated at a standard testing distance (typically 6 meters or 20 feet). A duochrome chart with black letters on a split red-green background is presented.
After determining the subjective refraction, a +1.00 diopter (DS) lens is added to the final prescription. The participant is asked to read the distance visual acuity (VA) chart. The expectation is that the visual acuity should drop to 4 lines on Snellen chart (6/24) when the +1.00 DS lens is added. If VA reduces to 6/24: Indicates that the refraction is not over-minused or over-plussed (proper end point of refraction). If VA remains better than 6/24: Suggests the patient was still accommodating, possibly leading to over-minus (in myopes) or under-plus (in hyperopes) and the refraction should be re-evaluated.
| Study group | Role | What they receive |
|---|---|---|
| duochrome test and +1 blur test (Group1) 18-35 | Experimental | Not described Receives: Diagnostic Test: duochrome test and +1 blur test |
| duochrome test and +1 blur test (Group1) 36-60 | Active comparator | Not described Receives: Diagnostic Test: duochrome test and +1 blur test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Function Index (VF-14) Questionnaire:
Scores on all activities that the person performed or did not perform because of vision were then averaged, yielding a value from 0 to 4. This value was multiplied by 25, giving a final score from 0 to 100. A score of 100 indicates able to do all applicable activities score of 0 indicates unable to do all applicable activities because of vision
Measured: 12 Months
+1 blur test
Adding a +1.00 diopter (DS) lens to a patient's final refraction and measuring their distance visual acuity (VA). There are 4 questions with 5 different options ranging from 0-4. minimum score is 0 and maximum score is 16 with spherical correction.
Measured: 12 Months
Duochrome Test
A duochrome test chart .There are 4 questions with 5 different options ranging from 0-4. minimum score is 0 and maximum score is 16 with spherical correction.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Mar 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001124
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/821
- Status last verified
- Jul 2025
- First submitted
- 23 May 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Duochrome Test Verse +1 Blur Test in Detecting Refracting Error Across Different Ages
- ClinicalTrials.gov ID
- NCT07001124
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/821
- Conditions
- Refractive Errors
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 3 Jun 2025 (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.
The comparative efficacy of the duochrome test versus +1 blur test in detecting refractive errors across different ages remains under-explored in current ophthalmic research. While the duochrome test is widely used to refine prescriptions, its standalone effectiveness compared to +1 blur test based refraction has not been thoroughly investigated.
Detailed description
This study aims to evaluate the efficacy, accuracy, and reliability of the duochrome test in identifying refractive errors, including myopia and hyperopia across various ages. Refractive errors, including myopia, hyperopia, and astigmatism, are leading causes of visual impairment, requiring precise diagnostic tools. The duochrome test utilizes chromatic aberration to refine prescriptions, whereas the +1 blur test assesses spherical correction accuracy. Despite their clinical use, direct comparative studies remain limited. A total of 33 participants with estimated 10% dropout randomly assigned to undergo both tests. Groups will be based on different ages, Group A (18-35 years)and group B (36-60 years) ..both test (Duochrome test and +1 blur test) will apply on every patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| duochrome test and +1 blur test (Group1) 18-35 | Experimental | Diagnostic Test: duochrome test and +1 blur test |
| duochrome test and +1 blur test (Group1) 36-60 | Active comparator | Diagnostic Test: duochrome test and +1 blur test |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 to 60 years old.
- Both genders.
- Those who have refractive error.
- Patients with no history of prior eye surgery.
- No active eye diseases affecting visual acuity, such as cataracts or retinal disorders.
Key exclusion criteria (4 listed)
- Patients with severe visual impairment or neurological conditions affecting vision.
- Patients with nystagmus or conditions that could interfere with reliable testing.
- Age below 18 year and above 60 year excluded
- Those patients who don't show their consent.
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 |
|---|---|---|
| duochrome test and +1 blur testThe participant is seated at a standard testing distance (typically 6 meters or 20 feet). A duochrome chart with black letters on a split red-green background is presented. After determining the subjective refraction, a +1.00 diopter (DS) lens is added to the final prescription. The participant is asked to read the distance visual acuity (VA) chart. The expectation is that the visual acuity should drop to 4 lines on Snellen chart (6/24) when the +1.00 DS lens is added. If VA reduces to 6/24: Indicates that the refraction is not over-minused or over-plussed (proper end point of refraction). If VA remains better than 6/24: Suggests the patient was still accommodating, possibly leading to over-minus (in myopes) or under-plus (in hyperopes) and the refraction should be re-evaluated. | Diagnostic test | duochrome test and +1 blur test (Group1) 18-35, duochrome test and +1 blur test (Group1) 36-60 |
Primary outcome
Visual Function Index (VF-14) Questionnaire:
Time frame: 12 Months
Scores on all activities that the person performed or did not perform because of vision were then averaged, yielding a value from 0 to 4. This value was multiplied by 25, giving a final score from 0 to 100. A score of 100 indicates able to do all applicable activities score of 0 indicates unable to do all applicable activities because of vision
+1 blur test
Time frame: 12 Months
Adding a +1.00 diopter (DS) lens to a patient's final refraction and measuring their distance visual acuity (VA). There are 4 questions with 5 different options ranging from 0-4. minimum score is 0 and maximum score is 16 with spherical correction.
Duochrome Test
Time frame: 12 Months
A duochrome test chart .There are 4 questions with 5 different options ranging from 0-4. minimum score is 0 and maximum score is 16 with spherical correction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing duochrome test and +1 blur test in people with Refractive Errors, run by Superior University at 1 site in Pakistan.
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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Visual Function Index (VF-14) Questionnaire: (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2025.