Visual ImpairmentCVTVNCT06224751
Developing Better Computerised Vision Tests (CVTV)
An observational study of Visual Impairment and Amblyopia, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Clinical vision measurements usually involve printed charts with an eye care professional interpreting patient responses to generate a score. Those scores determine the need for or outcome of treatment. Detecting change can be improved with strict procedures/scoring, lending itself to computerisation. Read more about this study
- Who is it for?
- Ages 3 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Impairment, Amblyopia, Macular Degeneration
- What is being tested?
- Near logMAR letter acuity, Near LogMAR word acuity and Red Green Stereoacuity
- How many people
- 550 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2024to Jan 2025
- Phase
- Observational
- 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 3 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients attending the outpatient eye clinics at St Thomas' Hospital NHS Foundation Trust
Who may be able to join
- Male and female patients attending hospital eye clinics, aged 3 - 99, inclusive.
- Patients able to understand the information sheet, and willing and able to give informed consent to participate.
- Patients with visual function ranging from normal to severely impaired.
- Willing and able to comply with the visual function testing protocol.
- Some validation studies require recruitment of disease specific groups (such as children with amblyopia or adults with age related macular degeneration).
- For Part B of the project which aims to develop and pilot a home monitoring application, only adult (18-99 years) subjects complying with the above who also own a suitable browser device will be recruited.
Who cannot join
- Unwilling or unable to comply with the visual function testing protocol.
- Unwilling or unable to give informed consent.
- Unwilling to participate.
- In other research trials.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St Thomas' Hospital NHS Foundation Trust
London
Abigail Orr, eyeresearch@gstt.nhs.uk
About this study
Official title: A Program to Develop Computerised Visual Function Tests for Cross Sectional Routine Clinical Practice and Long Term Monitoring to Detect Adverse Change in Visual Function.
Clinical vision measurements usually involve printed charts with an eye care professional interpreting patient responses to generate a score. Those scores determine the need for or outcome of treatment. Detecting change can be improved with strict procedures/scoring, lending itself to computerisation. This in turn allows integration with electronic medical records. Many eye tests could be computerised in this way. At Guys and St Thomas' NHS Foundation Trust, the investigators have developed and validated a computerised test of distance visual acuity, called COMPlog which is now in widespread use. The investigators now want to increase the range of tests available.
There is also a need to longitudinally monitor for adverse change. Such monitoring must be developed to keep false positive and false negative change detection to a minimum.
Read more
The aims of this two year linked program are to:
Part A) validate an extended range of computerised vision measurement tests against their gold standard hard copy printed equivalents. Some of these tests are designed for use in children and all are meant to quantify both normal and impaired vision. Patients of all ages and visual function will therefore be recruited from St Thomas' Hospital. The specific tests we aim to validate are logMAR Letter Near Acuity, Word Near Acuity, Letter Contrast Sensitivity, Auckland Optotypes Picture Acuity, Low Contrast Letter Acuity, Stereoacuity and Vanishing Optotypes. Patients will undergo test-retest measurements with up to two of these.
Part B) Iteratively develop an application for use in home monitoring of subjects at risk of treatable vision loss due to age related macular degeneration.
All computerised tests in parts A and B will be performed on prototype software. Eye patients will be recruited as subjects. Patients recruited to part A will undergo tests on one day for up to an hour, subjects in part B will participate for between 1 hour and two months.
- Conditions
- Visual Impairment, Amblyopia, Macular Degeneration, Ophthalmic Disease
- Being tested
- Near logMAR letter acuity, Near LogMAR word acuity, Red Green Stereoacuity, Auckland Optotype/Auckland Vanishing Optotypes, Vanishing Optotype Sloan Letters
- Keywords
- Visual acuity, Visual function, Ocular disease
- Medical subject headings
- Vision Disorders, Amblyopia, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near logMAR letter acuityDiagnostic test
Comparison of gold standard printed tests and computerised versions
Near LogMAR word acuityDiagnostic test
Comparison of gold standard printed tests and computerised versions
Red Green StereoacuityDiagnostic test
Comparison of gold standard printed tests and computerised versions
Auckland Optotype/Auckland Vanishing OptotypesDiagnostic test
Comparison of gold standard printed tests and computerised versions
Vanishing Optotype Sloan LettersDiagnostic test
Comparison of gold standard printed tests and computerised versions
Letter Contrast SensitivityDiagnostic test
Comparison of gold standard printed tests and computerised versions
Low Contrast Letter AcuityDiagnostic test
Comparison of gold standard printed tests and computerised versions
| Study group | Role | What they receive |
|---|---|---|
| Near logMAR letter acuity | Comparison of measurements made with the trial computerised test to the trial gold standard printed test Receives: Diagnostic Test: Near logMAR letter acuity | |
| Near logMAR word acuity | Comparison of measurements made with the trial computerised test to the trial gold standard printed test Receives: Diagnostic Test: Near LogMAR word acuity | |
| Letter Contrast Sensitivity | Comparison of measurements made with the trial computerised test to the trial gold standard printed test Receives: Diagnostic Test: Letter Contrast Sensitivity | |
| Vanishing Optotype Sloan letters | Comparison of measurements made with the trial computerised test to the trial gold standard printed test Receives: Diagnostic Test: Vanishing Optotype Sloan Letters | |
| Auckland Optotypes/Auckland Vanishing Optotypes | Comparison of measurements made with the trial computerised test to the trial gold standard printed test Receives: Diagnostic Test: Auckland Optotype/Auckland Vanishing Optotypes | |
| Low contrast letter acuity | Comparison of measurements made with the trial computerised test to the trial gold standard printed test Receives: Diagnostic Test: Low Contrast Letter Acuity | |
| Red Green Stereoacuity | Comparison of measurements made with the trial computerised test to the trial gold standard printed test Receives: Diagnostic Test: Red Green Stereoacuity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test agreement between the computerised vision measurement test and the gold standard hard copy test.
The test agreement is quantified in terms of the mean difference and 95% confidence interval of the mean in log units.
Measured: Through study completion, an average of 1 year
Test-retest variability for the computerised vision measurement test and the gold standard hard copy test.
Measurement variability (difference in two measures captured using the same vision test on the same day) will be quantified in log units for each vision test used in this study.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study startApr 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Alistair Laidlaw, MD FRCOphth, Principal investigator, St Thomas' Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224751
- Sponsor's protocol ID
- 277317
- Acronym
- CVTV
- Status last verified
- Mar 2024
- First submitted
- 25 Oct 2023
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Program to Develop Computerised Visual Function Tests for Cross Sectional Routine Clinical Practice and Long Term Monitoring to Detect Adverse Change in Visual Function.
- ClinicalTrials.gov ID
- NCT06224751
- Acronym / sponsor ID
- CVTV / 277317
- Conditions
- Visual Impairment, Amblyopia, Macular Degeneration, Ophthalmic Disease
- Keywords
- Visual acuity, Visual function, Ocular disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Apr 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 25 Jan 2024 (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.
Clinical vision measurements usually involve printed charts with an eye care professional interpreting patient responses to generate a score. Those scores determine the need for or outcome of treatment. Detecting change can be improved with strict procedures/scoring, lending itself to computerisation. This in turn allows integration with electronic medical records. Many eye tests could be computerised in this way. At Guys and St Thomas' NHS Foundation Trust, the investigators have developed and validated a computerised test of distance visual acuity, called COMPlog which is now in widespread use. The investigators now want to increase the range of tests available.
There is also a need to longitudinally monitor for adverse change. Such monitoring must be developed to keep false positive and false negative change detection to a minimum.
The aims of this two year linked program are to:
Part A) validate an extended range of computerised vision measurement tests against their gold standard hard copy printed equivalents. Some of these tests are designed for use in children and all are meant to quantify both normal and impaired vision. Patients of all ages and visual function will therefore be recruited from St Thomas' Hospital. The specific tests we aim to validate are logMAR Letter Near Acuity, Word Near Acuity, Letter Contrast Sensitivity, Auckland Optotypes Picture Acuity, Low Contrast Letter Acuity, Stereoacuity and Vanishing Optotypes. Patients will undergo test-retest measurements with up to two of these.
Part B) Iteratively develop an application for use in home monitoring of subjects at risk of treatable vision loss due to age related macular degeneration.
All computerised tests in parts A and B will be performed on prototype software. Eye patients will be recruited as subjects. Patients recruited to part A will undergo tests on one day for up to an hour, subjects in part B will participate for between 1 hour and two months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Near logMAR letter acuity | – | Diagnostic Test: Near logMAR letter acuityComparison of measurements made with the trial computerised test to the trial gold standard printed test |
| Near logMAR word acuity | – | Diagnostic Test: Near LogMAR word acuityComparison of measurements made with the trial computerised test to the trial gold standard printed test |
| Letter Contrast Sensitivity | – | Diagnostic Test: Letter Contrast SensitivityComparison of measurements made with the trial computerised test to the trial gold standard printed test |
| Vanishing Optotype Sloan letters | – | Diagnostic Test: Vanishing Optotype Sloan LettersComparison of measurements made with the trial computerised test to the trial gold standard printed test |
| Auckland Optotypes/Auckland Vanishing Optotypes | – | Diagnostic Test: Auckland Optotype/Auckland Vanishing OptotypesComparison of measurements made with the trial computerised test to the trial gold standard printed test |
| Low contrast letter acuity | – | Diagnostic Test: Low Contrast Letter AcuityComparison of measurements made with the trial computerised test to the trial gold standard printed test |
| Red Green Stereoacuity | – | Diagnostic Test: Red Green StereoacuityComparison of measurements made with the trial computerised test to the trial gold standard printed test |
Who may qualify
- Ages
- 3 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients attending the outpatient eye clinics at St Thomas' Hospital NHS Foundation Trust
Key inclusion criteria (6 listed)
- Male and female patients attending hospital eye clinics, aged 3 - 99, inclusive.
- Patients able to understand the information sheet, and willing and able to give informed consent to participate.
- Patients with visual function ranging from normal to severely impaired.
- Willing and able to comply with the visual function testing protocol.
- Some validation studies require recruitment of disease specific groups (such as children with amblyopia or adults with age related macular degeneration).
Key exclusion criteria (4 listed)
- Unwilling or unable to comply with the visual function testing protocol.
- Unwilling or unable to give informed consent.
- Unwilling to participate.
- In other research trials.
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 |
|---|---|---|
| Near logMAR letter acuityComparison of gold standard printed tests and computerised versions | Diagnostic test | Near logMAR letter acuity |
| Near LogMAR word acuityComparison of gold standard printed tests and computerised versions | Diagnostic test | Near logMAR word acuity |
| Red Green StereoacuityComparison of gold standard printed tests and computerised versions | Diagnostic test | Red Green Stereoacuity |
| Auckland Optotype/Auckland Vanishing OptotypesComparison of gold standard printed tests and computerised versions | Diagnostic test | Auckland Optotypes/Auckland Vanishing Optotypes |
| Vanishing Optotype Sloan LettersComparison of gold standard printed tests and computerised versions | Diagnostic test | Vanishing Optotype Sloan letters |
| Letter Contrast SensitivityComparison of gold standard printed tests and computerised versions | Diagnostic test | Letter Contrast Sensitivity |
| Low Contrast Letter AcuityComparison of gold standard printed tests and computerised versions | Diagnostic test | Low contrast letter acuity |
Primary outcome
Test agreement between the computerised vision measurement test and the gold standard hard copy test.
Time frame: Through study completion, an average of 1 year
The test agreement is quantified in terms of the mean difference and 95% confidence interval of the mean in log units.
Test-retest variability for the computerised vision measurement test and the gold standard hard copy test.
Time frame: Through study completion, an average of 1 year
Measurement variability (difference in two measures captured using the same vision test on the same day) will be quantified in log units for each vision test used in this study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- 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.
Alistair Laidlaw, MD FRCOphth principal investigator
St Thomas' Hospital, London
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 Visual Impairment and Amblyopia, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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: status not confirmed, as of the sponsor's last update on 18 Mar 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abigail Orr, BSc (020 7188 4885, eyeresearch@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test agreement between the computerised vision measurement test and the gold standard hard copy test. (time frame: Through study completion, an average of 1 year). 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?
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 18 Mar 2024.