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VISIODOL: Validation of the VISIODOL® Scale

U

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)

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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