GlaucomaD&GNCT05968547
Evaluation of Patients' Requirements for Improved Advice and Guidance on Vision Standards for Driving in Glaucoma
An observational study of Glaucoma, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Glaucoma can affect both central and peripheral vision. Clinicians need to discuss with patients the vision related driving standards and any specific limitations their patients may have relating to their ability to drive with glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Driving assessment in glaucoma patient
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Aug 2023to 25 Dec 2023
- 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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending glaucoma clinics.
Who may be able to join
- All patients attending the glaucoma clinic will be eligible for the survey.
- Both drivers and non-drivers will be included in the study.
- Glaucoma patients with habitual vision of 6/19 or better at least in one eye (whether driving or not driving).
Who cannot join
- All the patients attending glaucoma clinic, willing to participate in the study, will be eligible to participate in the survey and will not be excluded from the study.
- Patients with a binocular habitual visual acuity of less than 6/19 will not be able to eligible to participate in qualitative vision assessment.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester Royal Eye Hospital
Manchester, M13 9WH
Subash Sukumar, 01612766583, subash.sukumar@mft.nhs.uk
Subash Sukumar
About this study
Glaucoma can affect both central and peripheral vision. Clinicians need to discuss with patients the vision related driving standards and any specific limitations their patients may have relating to their ability to drive with glaucoma. According to the recent guidelines by the General Optical Council (GOC), clinicians are advised to make sure that the Driving and Vehicle Licensing Agency (DVLA) is informed about patients who do not meet the driving vision standards. There are several limitations in making a professional judgement about a patient's suitability to drive and in providing appropriate advice to patients. The main concern is discussing this sensitive issue with the patient based upon available clinical evidence e.g. vision or visual field and directing them to inform the DVLA of their condition or potentially advising them to stop driving. The purpose of this research is to investigate the two main issues 1. To explore patients' understanding of standards of vision for driving. 2. Comparing the standards of vision for driving estimated in the clinic with number plate vision. We propose to do a mixed methods analysis using a patient survey and quantitative investigation of driving vision standards.
Read the detailed description
The two main objectives that we propose to study in this project are
- Descriptive understanding of patients' perception of their driving needs and their understanding of driving standards. This will be studied with the help of a survey questionnaire to learn about patients' driving needs, sight history, understanding of DVLA vision standards and the driving advice given to them. Understanding glaucoma patients' general perceptions about standards of vision for driving and their driving needs will help us to improve communication with the patients and to give the best possible advice about standards of vision for driving.
- Quantitative comparison of standards of vision for driving as required by DVLA and clinical vision assessment in glaucoma patients. The limitations to meet the vision standard for driving will be assessed in glaucoma patients in the clinic and outside the clinic as required by DVLA standards of vision for driving. In the clinic, vision will be assessed by checking if the patient can binocularly read the 6/12 line on the vision chart and electronic number plate test used in the clinic. The results will be compared with a self-assessed number plate vision - a standard requirement to meet DVLA's standard of vision for driving. Understanding the clinical estimation of binocular vision, patients' ability to read the number plate in clinic and to self-assess their number plate vision will help the clinician to know patients' abilities and give evidence-based advice to the glaucoma patient about meeting the DVLA standards of vision.
- Conditions
- Glaucoma
- Being tested
- Driving assessment in glaucoma patient
- Keywords
- Driving Standards, DVLA, Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving assessment in glaucoma patientOther
Also called 1. questionnaire to patient. 2.Assessment of vision using visual acuity chart and number plate vision
One group of patient will be given questionnaire while the other group will respond to a questionnaire while the other group will have vision assessment. Patients could participate in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma patients questionnaire | Questionnaire to understand patients driving needs and understanding of driving vision standards | |
| Visual acuity standards | DVLA vision standard estimated in the clinic is compared with standandard car number plate outside the clinic. We estimate the vision in the clinic using standard visual acuity chart and electronic number plate vision and compare with number plate vision estimated outside the clinic by the patient. Instruction to estimate number plate vision will be provided to the patient. Receives: Other: Driving assessment in glaucoma patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to read 6/12 or above in vision chart with both eyes.
Binocular Vision assessment in Logmar testing
Measured: 6 months
Vision Chart score in each eye
Unilateral Vision testing Logmar testing
Measured: 6 months
Ability to read the number plate in the clinic displayed in the VDU
Ability to read the number plate in the clinic displayed in the VDU comparative visual display unit
Measured: 6 months
Ability to read the car number plate outside the clinic
Ability to read the car number plate outside the clinic as per patients self assessment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start25 Aug 2023 (estimated)
- Primary completion25 Oct 2023 (estimated)
- Study completion25 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Subash Sukumar, Principal investigator, Manchester Royal Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968547
- Sponsor's protocol ID
- B00964
- Acronym
- D&G
- Status last verified
- Jul 2023
- First submitted
- 19 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients' Requirements for Improved Advice and Guidance on Vision Standards for Driving in Glaucoma
- ClinicalTrials.gov ID
- NCT05968547
- Acronym / sponsor ID
- D&G / B00964
- Conditions
- Glaucoma
- Keywords
- Driving Standards, DVLA, Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 25 Aug 2023 (estimated)
- Primary completion
- 25 Oct 2023 (estimated)
- Study completion
- 25 Dec 2023 (estimated)
- First posted
- 1 Aug 2023 (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.
Glaucoma can affect both central and peripheral vision. Clinicians need to discuss with patients the vision related driving standards and any specific limitations their patients may have relating to their ability to drive with glaucoma. According to the recent guidelines by the General Optical Council (GOC), clinicians are advised to make sure that the Driving and Vehicle Licensing Agency (DVLA) is informed about patients who do not meet the driving vision standards. There are several limitations in making a professional judgement about a patient's suitability to drive and in providing appropriate advice to patients. The main concern is discussing this sensitive issue with the patient based upon available clinical evidence e.g. vision or visual field and directing them to inform the DVLA of their condition or potentially advising them to stop driving. The purpose of this research is to investigate the two main issues 1. To explore patients' understanding of standards of vision for driving. 2. Comparing the standards of vision for driving estimated in the clinic with number plate vision. We propose to do a mixed methods analysis using a patient survey and quantitative investigation of driving vision standards.
Detailed description
The two main objectives that we propose to study in this project are
- Descriptive understanding of patients' perception of their driving needs and their understanding of driving standards. This will be studied with the help of a survey questionnaire to learn about patients' driving needs, sight history, understanding of DVLA vision standards and the driving advice given to them. Understanding glaucoma patients' general perceptions about standards of vision for driving and their driving needs will help us to improve communication with the patients and to give the best possible advice about standards of vision for driving.
- Quantitative comparison of standards of vision for driving as required by DVLA and clinical vision assessment in glaucoma patients. The limitations to meet the vision standard for driving will be assessed in glaucoma patients in the clinic and outside the clinic as required by DVLA standards of vision for driving. In the clinic, vision will be assessed by checking if the patient can binocularly read the 6/12 line on the vision chart and electronic number plate test used in the clinic. The results will be compared with a self-assessed number plate vision - a standard requirement to meet DVLA's standard of vision for driving. Understanding the clinical estimation of binocular vision, patients' ability to read the number plate in clinic and to self-assess their number plate vision will help the clinician to know patients' abilities and give evidence-based advice to the glaucoma patient about meeting the DVLA standards of vision.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma patients questionnaire | – | –Questionnaire to understand patients driving needs and understanding of driving vision standards |
| Visual acuity standards | – | Other: Driving assessment in glaucoma patientDVLA vision standard estimated in the clinic is compared with standandard car number plate outside the clinic. We estimate the vision in the clinic using standard visual acuity chart and electronic number plate vision and compare with number plate vision estimated outside the clinic by the patient. Instruction to estimate number plate vision will be provided to the patient. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending glaucoma clinics.
Key inclusion criteria (3 listed)
- All patients attending the glaucoma clinic will be eligible for the survey.
- Both drivers and non-drivers will be included in the study.
- Glaucoma patients with habitual vision of 6/19 or better at least in one eye (whether driving or not driving).
Key exclusion criteria (2 listed)
- All the patients attending glaucoma clinic, willing to participate in the study, will be eligible to participate in the survey and will not be excluded from the study.
- Patients with a binocular habitual visual acuity of less than 6/19 will not be able to eligible to participate in qualitative vision assessment.
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 |
|---|---|---|
| Driving assessment in glaucoma patientAlso: 1. questionnaire to patient. 2.Assessment of vision using visual acuity chart and number plate visionOne group of patient will be given questionnaire while the other group will respond to a questionnaire while the other group will have vision assessment. Patients could participate in both groups. | Other | Visual acuity standards |
Primary outcome
Ability to read 6/12 or above in vision chart with both eyes.
Time frame: 6 months
Binocular Vision assessment in Logmar testing
Vision Chart score in each eye
Time frame: 6 months
Unilateral Vision testing Logmar testing
Ability to read the number plate in the clinic displayed in the VDU
Time frame: 6 months
Ability to read the number plate in the clinic displayed in the VDU comparative visual display unit
Ability to read the car number plate outside the clinic
Time frame: 6 months
Ability to read the car number plate outside the clinic as per patients self assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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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.
Subash Sukumar principal investigator
Manchester Royal Eye Hospital
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 Glaucoma, run by Manchester University 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 3 inclusion and 2 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 1 Aug 2023. 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 Subash Sukumar (0161-276-6583, subash.sukumar@mft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to read 6/12 or above in vision chart with both eyes. (time frame: 6 months). The study lists 4 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 1 Aug 2023.