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TerminatedNCT03296111QUALVIDONUpdated Oct 30, 2019

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

An observational study in Dry Eye Syndromes, Neuralgia and Pain, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-30.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Why this study was terminated
Difficulties for patients inclusion
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
19
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dry Eye Syndromes
  • Neuralgia
  • Pain
  • Quality of Life
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients with ocular neuropathic pain.

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

Exclusion Criteria:

  • Severe corneal or palpebral damage explaining current pain
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
19 participants (actual)
Patient registry
No

Interventions

  • OtherQuestionnaires 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)

05

What researchers measure

Primary outcomes

  1. Scores obtained with each questionnaires.

    Time frame: baseline

06

Study locations

1 site
  • Fondation Ophtamologique A. de Rothschild
    Paris, 75019, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03296111
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Sep 28, 2017
Start date
May 4, 2017
Primary completion
Jun 19, 2017
Completion
Oct 28, 2019
Last update
Oct 30, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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