Evaluation of Patients' Requirements for Improved Advice and Guidance on Vision Standards for Driving in Glaucoma

NCT05968547 | Unknown

• 1 other identifier: B00964
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

Driving Standards; DVLA; Glaucoma

Outcome Measures

Primary Outcomes (4)

• Ability to read 6/12 or above in vision chart with both eyes.

  Binocular Vision assessment in Logmar testing

  6 months

• Vision Chart score in each eye

  Unilateral Vision testing Logmar testing

  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

  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

  6 months

Study Arms (2)

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.

Other: Driving assessment in glaucoma patient

Interventions

Driving assessment in glaucoma patient OTHER

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.

Also known as: 1. questionnaire to patient. 2.Assessment of vision using visual acuity chart and number plate vision

Visual acuity standards

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients attending glaucoma clinics.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester Royal Eye Hospital

Manchester, M13 9WH, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Subash Sukumar

  Manchester Royal Eye Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Subash Sukumar

CONTACT

0161-276-6583; subash.sukumar@mft.nhs.uk

Subash Sukumar

CONTACT

01612766583; subash.sukumar@mft.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 1, 2023
• Study Start: August 25, 2023
• Primary Completion: October 25, 2023
• Study Completion: December 25, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

GB (1)