NCT03968991

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

June 18, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2020

Completed
Last Updated

March 13, 2023

Status Verified

January 1, 2022

Enrollment Period

1.5 years

First QC Date

April 29, 2019

Last Update Submit

March 9, 2023

Conditions

Visual DeficiencyCongenital BlindnessAcquired Blindness

Keywords

Blinded populationPain evaluationDiagnostic tool

Outcome Measures

Primary Outcomes (1)

  • Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using thermal tests.

    Determination of the correlation coefficient between NS and VISIODOL® scale for different pain temperatures by hot thermal tests. The rating of the NS and VISIODOL® scales can range from 0 to 10.

    Day 0 + 2 hours

Secondary Outcomes (10)

  • Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using thermal tests.

    Day 0 + 2 hours

  • Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using thermal tests .

    Day 0 + 2 hours

  • Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using thermal tests.

    Day 0 + 2 hours

  • Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using mechanical tests.

    Day 0 + 2 hours

  • Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using mechanical tests.

    Day 0 + 2 hours

  • +5 more secondary outcomes

Study Arms (3)

Healthy volunteer group

ACTIVE COMPARATOR

male or female healthy volunteers

Diagnostic Test: VISIODOL® (Diagnostic tool)

Subjects with acquired visual impairment

EXPERIMENTAL

visual acquired disability

Diagnostic Test: VISIODOL® (Diagnostic tool)

Subjects with congenital visual impairment

EXPERIMENTAL

Visual congenital disability

Diagnostic Test: VISIODOL® (Diagnostic tool)

Interventions

VISIODOL® (Diagnostic tool)DIAGNOSTIC_TEST

Tool for assessing pain in the blind subject (with congenital or acquired deficiency)

Healthy volunteer groupSubjects with acquired visual impairmentSubjects with congenital visual impairment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Subjects under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • Pickering G, Morel V, Goubayon J, Touron A, Leray V, Pereira B. A tactile pain evaluation scale for persons with visual deficiencies. Pain Med. 2023 Jul 5;24(7):855-861. doi: 10.1093/pm/pnad013.

    PMID: 36809402DERIVED

MeSH Terms

Conditions

Blindness

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gisèle Pickering

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2019

First Posted

May 31, 2019

Study Start

June 18, 2019

Primary Completion

December 28, 2020

Study Completion

December 28, 2020

Last Updated

March 13, 2023

Record last verified: 2022-01

Locations

FR(1)