VISIODOL: Validation of the VISIODOL® Scale

University Hospital, Clermont-Ferrand

Status: Terminated

Conditions: Congenital Blindness; Acquired Blindness; Visual Deficiency

Treatments: Diagnostic Test: VISIODOL® (Diagnostic tool)

Study type: Interventional

Funder types: Other

Identifiers

NCT03968991

2018-A03370-55 (Other Identifier)

RBHP 2018 PICKERING 2

Details and patient eligibility

About

The aim of this study is to validate the VISIODOL® scale for screening of pain in people with visual impairment.

Full description

The VISIODOL® monocentric study conducted at Clermont-Ferrand University Hospital is a cross-disciplinary diagnostic tool validation performed in patients with acquired or congenital visual impairment and healthy sighted volunteers. Different evaluations by thermal (Pathway Médoc®) and mechanical (electronic Von Frey®) tests will allow to compare the new VISIODOL® scale with the numerical scale, which is a commonly used tool. The ergonomic quality, the satisfaction of use and the quality of life, stress, anxiety and catastrophism of the patients will also be studied.

Enrollment: 37 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers
• Subjects aged over 18 / under 60
• Male or female
• Subjects fasting from coffee, tea, Coca-Cola and others stimulants
• Sufficient understanding and cooperation to comply with the study requirements
• Agreed to provide written consent
• Affiliated to the social security
• Subjects with visual impairment (congenital or acquired)
• Subjects with no visual impairment (healthy group)

Exclusion criteria

• Subjects under 18 years old
• Administrative and legal criteria (tutorship, curatorship, without social security, in exclusion period of another study)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 3 patient groups

Healthy volunteer group

Active Comparator group

Description:

male or female healthy volunteers

Treatment:

Diagnostic Test: VISIODOL® (Diagnostic tool)

Subjects with acquired visual impairment

Experimental group

Description:

visual acquired disability

Treatment:

Diagnostic Test: VISIODOL® (Diagnostic tool)

Subjects with congenital visual impairment

Experimental group

Description:

Visual congenital disability

Treatment:

Diagnostic Test: VISIODOL® (Diagnostic tool)