The Value of Visual Field Examination in Driving Licence.

NCT ID: NCT04671550

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-12-31

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.

Detailed Description

In this observational study, the investigators recruite patients referred at the Glaucoma Service of the Ophthalmologic Clinic of the ASST Sette Laghi University Hospital in Varese.

All the patients enrolled in the study require 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.

All patients undergo a full ophthalmologic examination and verbally submitted a questionnaire designed by the authors of the paper (LL, SD, MD).

The examination included Visual Acuity, refraction, slit lamp bio-microscospy, Goldmann's applanation tonometry, gonioscopy with four mirror lens, OCT RNFL and GCL imaging if necessary and re-evaluation of target IOP.

The investigators use the two monocular visual fields to build an Integrated Visual Field which, according to D.P. Crabb papers, is an efficient surrogate to the Binocular Esterman Visual Field Test (EVFT). In short, each point in each monocular field is compared to its equivalent in the other eye, and the data, from the eye with the best sensitivity, are used. Locations are dichotomized into groups with sensitivity > 10 dB and < 10 dB, representing whether a patient would see or miss a point in the Esterman test, respectively. To match even better the IVF with the EVFT, 8 points of the inner 20° of the IVF were excluded since they have no direct equivalent in the EVFT.

Conditions

Glaucoma Eye

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

questionnaire

Questionnaire on "Driving performances and Visual Field"

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi dell'Insubria

OTHER

Sponsor Role: lead

Responsible Party

Simone Donati

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ASST Sette Laghi

Varese, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Simone Donati, MD

Role: primary

simone.donati@uninsubria.it

00393333615015

Other Identifiers

2020/Glaucoma

Identifier Type: -

Identifier Source: org_study_id