Visual DeficiencyVISIODOLNCT03968991
VISIODOL: Validation of the VISIODOL® Scale
A study testing VISIODOL® (Diagnostic tool) in people with Visual Deficiency and Congenital Blindness, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim of this study is to validate the VISIODOL® scale for screening of pain in people with visual impairment. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Deficiency, Congenital Blindness, Acquired Blindness
- What is being tested?
- VISIODOL® (Diagnostic tool)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2019to 28 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Affiliated to the social security
- Subjects with visual impairment (congenital or acquired)
- Subjects with no visual impairment (healthy group)
Who cannot join
- Subjects under 18 years old
- Administrative and legal criteria (tutorship, curatorship, without social security, in exclusion period of another study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Visual Deficiency, Congenital Blindness, Acquired Blindness
- Being tested
- VISIODOL® (Diagnostic tool)
- Keywords
- Blinded population, Pain evaluation, Diagnostic tool
- Medical subject headings
- Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VISIODOL® (Diagnostic tool)Diagnostic test
Tool for assessing pain in the blind subject (with congenital or acquired deficiency)
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer group | Active comparator | male or female healthy volunteers Receives: Diagnostic Test: VISIODOL® (Diagnostic tool) |
| Subjects with acquired visual impairment | Experimental | visual acquired disability Receives: Diagnostic Test: VISIODOL® (Diagnostic tool) |
| Subjects with congenital visual impairment | Experimental | Visual congenital disability Receives: Diagnostic Test: VISIODOL® (Diagnostic tool) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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 .
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Day 0 + 2 hours
Comparison of pain perception between the 3 groups
comparison of NS and VISIODOL® scoring for pain threshold by hot thermal tests (Pathway Medoc®).
Measured: Day 0 + 1 hour
Evaluation of the ergonomic qualities of the scale
ergonomic survey : Different ergonomic parameters such as length, width and granulometry will be evaluated using a questionnaire.
Measured: Day 0 + 1 hour
Evaluation of satisfaction of the use of the scale
satisfaction survey : The satisfaction of the participants in the study will be collected by means of a questionnaire.
Measured: Day 0 + 1 hour
Evaluation of anxiety
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.
Measured: Day 0 + 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start18 Jun 2019
- Primary completion28 Dec 2020
- Study completion28 Dec 2020
Why it stopped: low recruits
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visual DeficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisèle Pickering, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968991
- Sponsor's protocol ID
- RBHP 2018 PICKERING 2
- Other IDs
- 2018-A03370-55
- Acronym
- VISIODOL
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2019
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36809402
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VISIODOL: Validation of the VISIODOL® Scale for Screening of Pain in People With Visual Impairment
- ClinicalTrials.gov ID
- NCT03968991
- Acronym / sponsor ID
- VISIODOL / RBHP 2018 PICKERING 2
- Conditions
- Visual Deficiency, Congenital Blindness, Acquired Blindness
- Keywords
- Blinded population, Pain evaluation, Diagnostic tool
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruits
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to validate the VISIODOL® scale for screening of pain in people with visual impairment.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer group | Active comparator | Diagnostic Test: VISIODOL® (Diagnostic tool)male or female healthy volunteers |
| Subjects with acquired visual impairment | Experimental | Diagnostic Test: VISIODOL® (Diagnostic tool)visual acquired disability |
| Subjects with congenital visual impairment | Experimental | Diagnostic Test: VISIODOL® (Diagnostic tool)Visual congenital disability |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects under 18 years old
- Administrative and legal criteria (tutorship, curatorship, without social security, in exclusion period of another study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VISIODOL® (Diagnostic tool)Tool for assessing pain in the blind subject (with congenital or acquired deficiency) | Diagnostic test | Healthy volunteer group, Subjects with acquired visual impairment, Subjects with congenital visual impairment |
Primary outcome
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.
10 secondary outcomes
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
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
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
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
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
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
Comparison of pain perception between the 3 groups
Time frame: Day 0 + 1 hour
Evaluation of the ergonomic qualities of the scale
Time frame: Day 0 + 1 hour
Evaluation of satisfaction of the use of the scale
Time frame: Day 0 + 1 hour
Evaluation of anxiety
Time frame: Day 0 + 1 hour
Results and safety
The study was stopped early (reason given: low recruits). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 36809402Pickering 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.
Related trials for Visual Deficiency
Not yet recruiting
Sleep, Light, Circadian, Central Oxidative Stress
Non-visual Effects of Light, Chronic Variable Sleep Deficiency
Recruiting
Investigating Brain Function in People With and Without Visual Snow Syndrome Using Adaptation to Visual Stimuli
Visual Snow Syndrome, Migraine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisèle Pickering principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VISIODOL® (Diagnostic tool) in people with Visual Deficiency and Congenital Blindness, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low recruits). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026; AzTrials last refreshed its copy on 3 Nov 2026.