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Patients With Ocular Neuropathic Pain: Description of Pain and Impact on Their Quality of Life (QUALVIDON)

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ClinicalTrials.gov Identifier: NCT03296111
Recruitment Status : Terminated (Difficulties for patients inclusion)
First Posted : September 28, 2017
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:

Some patients with dry eye may have severe disabling neuropathic pain. They describe spontaneous pain, dysesthesia, hyperalgesia or even allodynia. It is classical to note an important discordance between the high intensity of the symptoms and the poverty of the clinical signs. These pains are often unrecognized and therefore often not sufficiently treated. A significant impact on patient's quality of life may occur. The concept of ocular neuropathic pain being relatively recent, few studies have focused on the subject at present. Our study aims to shed light on these pains in patients consulting for dry eyes at the Ophthalmological Foundation A. de Rothschild.

The objective of our study is to describe precisely the characteristics of neuropathic eye pain and the visual, general and psychological repercussions in these patients.


Condition or disease Intervention/treatment
Dry Eye Syndromes Neuralgia Pain Quality of Life Other: Questionnaires on pain and quality of life

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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Patients With Ocular Neuropathic Pain: Description of Pain and Impact on Their Quality of Life
Actual Study Start Date : May 4, 2017
Actual Primary Completion Date : June 19, 2017
Actual Study Completion Date : October 28, 2019

Intervention Details:
  • Other: Questionnaires on pain and quality of life

    Patients will be asked to complete several questionnaires about their pain and the impact on their quality of life.

    They will complete the questionnaires in the ophthalmology consultation room or at home and return it by mail (or present it at the next consultation).

    Patients will be asked to complete several questionnaires :

    • Questionnaire about the characteristics of ocular neuropathic pain (7 items)
    • DEQ-5 (Dry Eye Questionnaire)
    • ODI (Ocular Surface Disease Index)
    • BPI (Brief Pain Inventory)
    • HADS (Hospital Anxiety and Depression Scale)


Primary Outcome Measures :
  1. Scores obtained with each questionnaires. [ Time Frame: baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with ocular neuropathic pain.
Criteria

Inclusion Criteria:

  • Patient aged 18 years or older,
  • Presenting at least one of the following symptoms: spontaneous pain, burning sensation in eye, dysesthesia, allodynia, hyperalgesia
  • French language-skills

Exclusion Criteria:

  • Severe corneal or palpebral damage explaining current pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296111


Locations
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France
Fondation Ophtamologique A. de Rothschild
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03296111     History of Changes
Other Study ID Numbers: SDN_2017_9
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuralgia
Dry Eye Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Lacrimal Apparatus Diseases
Eye Diseases