Clinical trial NCT05968547: Evaluation of Patients' Requirements for Improved Advice and Guidance on Vision Standards for Driving in Glaucoma
Official title: Evaluation of Patients' Requirements for Improved Advice and Guidance on Vision Standards for Driving in Glaucoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glaucoma
Keywords: Driving Standards
DVLA
Glaucoma
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2023-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients attending glaucoma clinics.

Brief 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. 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

1. 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.
2. 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.

Eligibility criteria: Inclusion criteria for Patient survey:

* All patients attending the glaucoma clinic will be eligible for the survey.
* Both drivers and non-drivers will be included in the study.

Inclusion Criteria for Quantitative vision estimation:

• Glaucoma patients with habitual vision of 6/19 or better at least in one eye (whether driving or not driving).

Exclusion criteria for Patient survey:

• 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.

Exclusion Criteria for Quantitative vision estimation:

• Patients with a binocular habitual visual acuity of less than 6/19 will not be able to eligible to participate in qualitative vision assessment.

Primary outcomes:
measure: Ability to read 6/12 or above in vision chart with both eyes.
timeFrame: 6 months
measure: Vision Chart score in each eye
timeFrame: 6 months
measure: Ability to read the number plate in the clinic displayed in the VDU
timeFrame: 6 months
measure: Ability to read the car number plate outside the clinic
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Royal Eye Hospital
Study officials:
affiliation: Manchester Royal Eye Hospital
name: Subash Sukumar
role: PRINCIPAL_INVESTIGATOR
References: