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

Pain Clinical Trial

— QUALVIDON  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03296111
• Other study ID #: SDN_2017_9
• Status: Terminated
• Start date: May 4, 2017
• Est. completion date: October 28, 2019

Study information

• Verified date: October 2019
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: October 28, 2019
• Est. primary completion date: June 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Neuralgia
• Pain
• Quality of Life

Intervention

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)

Locations

Country	Name	City	State
France	Fondation Ophtamologique A. de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores obtained with each questionnaires.		baseline