The Value of Visual Field Examination in Driving Licence.
Glaucoma and Driving Licence: How to Identify Patients at Risk of Having it Revoked
1 other identifier
observational
200
1 country
1
Brief Summary
The aim of the study is to identify clinical criteria, easily achievable with patient's follow-up tests, which can identify individuals at increased risk of being unfit to drive. Only they, then, will be directed to further investigations. These clinical standards should also be suitable for implementing or substituting the current law's criteria, after appropriate additional studies, so that the law can be based on the clinic.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 29, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedSeptember 28, 2021
September 1, 2021
11 months
November 29, 2020
September 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of Visual Field quality by combining two parameters obtained by Computerized Visual Field Examination: number of missed points within the central 20° visual field and average Sensitivity (AS) of all the 60 points of the 24-2 grid
The Visual Field quality will be evaluated by considering two variables: Number of missed points within the central 20° visual field (expressed in number) and average Sensitivity (AS) of all the 60 points of the 24-2 grid (expressed in decibel, dB)
Baseline
Secondary Outcomes (1)
Creation of a Integrated Visual Field of both eyes
Baseline
Interventions
Questionnaire on "Driving performances and Visual Field"
Eligibility Criteria
The investigators recruite patients referred at the Glaucoma Service of the Ophthalmologic Clinic of the ASST Sette Laghi University Hospital in Varese
You may qualify if:
- subjects above 18 years of age
- clear diagnosis of Glaucoma (of any type)
- to show a reliable (less than 15% of false positive or false negative and no more than 33% of loss of fixation) visual field examination (Humphrey SITA 24-2 or 30-2 SITA Standard) performed in the previous six months.
You may not qualify if:
- other ocular conditions that could affect the visual field (i.e. cataract or macular degeneration).
- patients that underwent a 10-2 test since it does not allow the composition of the Integrated Visual Field.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ASST Sette Laghi
Varese, 21100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 29, 2020
First Posted
December 17, 2020
Study Start
November 1, 2020
Primary Completion
October 1, 2021
Study Completion
December 1, 2021
Last Updated
September 28, 2021
Record last verified: 2021-09