Refractive ErrorsNCT06913491
Efficacy of PEEK Acuity Versus ETDRS Chart for Assessment of Visual Acuity and Refractive Error
An observational study of Refractive Errors, run by Superior University at 1 site in Pakistan.
Trial summary
Visual acuity is a key indicator of visual function, often measured using the ETDRS chart, the gold standard in clinical settings. However, the increasing need for accessible and cost-effective screening tools, especially in underserved areas, has led to the development of mobile health applications like the Peek… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors
- How many people
- 51 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Visual acuity is a key indicator of visual function, often measured using the ETDRS chart, the gold standard in clinical settings. However, the increasing need for accessible and cost-effective screening tools, especially in underserved areas,
Who may be able to join
- Males and females.
- 18 years of age or older.
- Individuals with normal vision or those with refractive error who had their corrected glasses.
- Individuals who are willing and able to provide written informed consent to participate in the study.
Who cannot join
- Individuals with anterior segment abnormalities such as conjunctivitis, Iritis, uveitis, keratitis, or corneal ulcers.
- Individuals with vision deprivation due to corneal opacities, cataracts, glaucoma, retinal, and optic nerve pathologies.
- Postoperative/intraoperative complications.
- Have received mydriatic drops.
- Individuals who cannot achieve normal visual acuity with corrective lenses (glasses or contact lenses).
- Individuals with neurological conditions affecting vision
- Individuals unable to cooperate with visual acuity testing due to cognitive impairments or language barriers.
- Individuals who have had refractive surgery or other eye treatments within the past 6 months.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Eagle Eyes Relief Trust FF120, Divine mega 2, new airport road
Lahore, Punjab Province
About this study
Visual acuity is a key indicator of visual function, often measured using the ETDRS chart, the gold standard in clinical settings. However, the increasing need for accessible and cost-effective screening tools, especially in underserved areas, has led to the development of mobile health applications like the Peek Acuity application.
Read the detailed description
This study aims to compare the diagnostic accuracy and efficiency of the Peek acuity application (Portable Eye Examination Kit) with the ETDRS (Early Treatment of Diabetic Retinopathy Study) chart in assessing visual acuity and refractive errors. The study will involve 58 participants, selected using a non-probability convenience sampling technique. A comparative cross-sectional design will be used.
- Conditions
- Refractive Errors
- Medical subject headings
- Refractive Errors
What is being measured
The primary outcome is the main question the study is designed to answer.
Peek Acuity
Peek Acuity is easier to administer than an equivalent wall chart, such as Snellen or ETDRS, and is generally quicker to complete. The algorithm that controls progress through each test is optimised for clinical accuracy, so the test will end just as soon as a reliable score has been obtained.
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 posted6 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 51 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
- NCT06913491
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/803
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of PEEK Acuity Versus ETDRS Chart for Assessment of Visual Acuity and Refractive Error
- ClinicalTrials.gov ID
- NCT06913491
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/803
- Conditions
- Refractive Errors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 6 Apr 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.
Visual acuity is a key indicator of visual function, often measured using the ETDRS chart, the gold standard in clinical settings. However, the increasing need for accessible and cost-effective screening tools, especially in underserved areas, has led to the development of mobile health applications like the Peek Acuity application.
Detailed description
This study aims to compare the diagnostic accuracy and efficiency of the Peek acuity application (Portable Eye Examination Kit) with the ETDRS (Early Treatment of Diabetic Retinopathy Study) chart in assessing visual acuity and refractive errors. The study will involve 58 participants, selected using a non-probability convenience sampling technique. A comparative cross-sectional design will be used.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Visual acuity is a key indicator of visual function, often measured using the ETDRS chart, the gold standard in clinical settings. However, the increasing need for accessible and cost-effective screening tools, especially in underserved areas,
Key inclusion criteria (4 listed)
- Males and females.
- 18 years of age or older.
- Individuals with normal vision or those with refractive error who had their corrected glasses.
- Individuals who are willing and able to provide written informed consent to participate in the study.
Key exclusion criteria (8 listed)
- Individuals with anterior segment abnormalities such as conjunctivitis, Iritis, uveitis, keratitis, or corneal ulcers.
- Individuals with vision deprivation due to corneal opacities, cataracts, glaucoma, retinal, and optic nerve pathologies.
- Postoperative/intraoperative complications.
- Have received mydriatic drops.
- Individuals who cannot achieve normal visual acuity with corrective lenses (glasses or contact lenses).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peek Acuity
Time frame: 12 Months
Peek Acuity is easier to administer than an equivalent wall chart, such as Snellen or ETDRS, and is generally quicker to complete. The algorithm that controls progress through each test is optimised for clinical accuracy, so the test will end just as soon as a reliable score has been obtained.
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 6 Apr 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?
An observational study of 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 4 inclusion and 8 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 6 Apr 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?
Peek Acuity (time frame: 12 Months). 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 6 Apr 2025.