An interventional study of VISIODOL® (Diagnostic tool) in Visual Deficiency, Congenital Blindness and Acquired Blindness, sponsored by University Hospital, Clermont-Ferrand. Terminated at 1 site in France. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic
The aim of this study is to validate the VISIODOL® scale for screening of pain in people with visual impairment.
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.
144 studies on the registry are indexed under Blindness; 33 are open to participants now.
This study's enrollment of 37 is close to the median of 37 across 101 interventional studies indexed under Blindness.
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Exclusion Criteria:
male or female healthy volunteers
Diagnostic Test: VISIODOL® (Diagnostic tool)
visual acquired disability
Diagnostic Test: VISIODOL® (Diagnostic tool)
Visual congenital disability
Diagnostic Test: VISIODOL® (Diagnostic tool)
Tool for assessing pain in the blind subject (with congenital or acquired deficiency)
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.
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.
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.
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 .
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: 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®).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0 + 1 hour
This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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