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

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.

Study Overview

• Status: Terminated
• Conditions: Quality of Life; Pain; Neuralgia; Dry Eye Syndromes
• Intervention / Treatment: Other: Questionnaires on pain and quality of life

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Fondation Ophtamologique A. de Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients with ocular neuropathic pain.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Scores obtained with each questionnaires.	baseline

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2017
• Primary Completion (Actual): June 19, 2017
• Study Completion (Actual): October 28, 2019

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Lacrimal Apparatus Diseases; Neuralgia; Dry Eye Syndromes
• Other Study ID Numbers: SDN_2017_9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No