VISIODOL: Validation of the VISIODOL® Scale (VISIODOL)

August 5, 2026 updated by: University Hospital, Clermont-Ferrand

VISIODOL: Validation of the VISIODOL® Scale for Screening of Pain in People With Visual Impairment

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Healthy volunteer group
male or female healthy volunteers
Diagnostic test: VISIODOL® (Diagnostic tool)
Tool for assessing pain in the blind subject (with congenital or acquired deficiency)
Experimental: Subjects with acquired visual impairment
visual acquired disability
Diagnostic test: VISIODOL® (Diagnostic tool)
Tool for assessing pain in the blind subject (with congenital or acquired deficiency)
Experimental: Subjects with congenital visual impairment
Visual congenital disability
Diagnostic test: VISIODOL® (Diagnostic tool)
Tool for assessing pain in the blind subject (with congenital or acquired deficiency)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Day 0 + 2 hours
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Day 0 + 2 hours
Determination of the correlation coefficient between NS and VISIODOL® scale for sensitive threshold by hot thermal tests. The rating of the NS and VISIODOL® scales can range from 0 to 10.
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 .
Time Frame: Day 0 + 2 hours
Determination of the correlation coefficient between NS and VISIODOL® scale for sensitive threshold by cold thermal tests. The rating of the NS and VISIODOL® scales can range from 0 to 10.
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.
Time Frame: Day 0 + 2 hours
Determination of the correlation coefficient between NS and VISIODOL® scale for pain threshold by cold thermal tests. The rating of the NS and VISIODOL® scales can range from 0 to 10.
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.
Time Frame: Day 0 + 2 hours
Determination of the correlation coefficient between NS and VISIODOL® scale for sensitive threshold by electronic Von Frey®. The rating of the NS and VISIODOL® scales can range from 0 to 10.
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.
Time Frame: Day 0 + 2 hours
Determination of the correlation coefficient between NS and VISIODOL® scale for pain threshold by electronic Von Frey. The rating of the NS and VISIODOL® scales can range from 0 to 10.
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.
Time Frame: Day 0 + 2 hours
Determination of the correlation coefficient between NS and VISIODOL® scale for tolerance threshold by electronic Von Frey. The rating of the NS and VISIODOL® scales can range from 0 to 10.
Day 0 + 2 hours
Comparison of pain perception between the 3 groups
Time Frame: Day 0 + 1 hour
comparison of NS and VISIODOL® scoring for pain threshold by hot thermal tests (Pathway Medoc®).
Day 0 + 1 hour
Evaluation of the ergonomic qualities of the scale
Time Frame: Day 0 + 1 hour
ergonomic survey : Different ergonomic parameters such as length, width and granulometry will be evaluated using a questionnaire.
Day 0 + 1 hour
Evaluation of satisfaction of the use of the scale
Time Frame: Day 0 + 1 hour
satisfaction survey : The satisfaction of the participants in the study will be collected by means of a questionnaire.
Day 0 + 1 hour
Evaluation of anxiety
Time Frame: Day 0 + 1 hour
Hospital and Anxiety Depression Scale (HAD) : The Hospital Anxiety and Depression scale is a self-administered questionnaire in 14 items completed by the patient. It is used to determine the levels of anxiety and depression. Seven of the items relate to anxiety and seven relate to depression. Global score ranges from 0 to 42.
Day 0 + 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gisèle PICKERING, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RBHP 2018 PICKERING 2
  • 2018-A03370-55 (Other Identifier: 2018-A03370-55)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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