Dry Eye, Neuropathic Pain
Conditions
Keywords
Dry eye, Neuropathic eye pain, Quality of Life
Brief summary
Dry eye affects millions of people around the world. Some dry eye patients complain of neuropathic eye pain that can affect their quality of life. From August 2016 to June 2017, the QUALVIDON study (NCT03296111), conducted at the Adolphe de Rothschild Foundation Hospital, assessed pain and its impact on quality of life using self-administered questionnaires in a series of dry eye patients. This 2nd study, entitled QUALVIDON2, focuses on the outcome of patients previously included in QUALVIDON.
Interventions
* Neuropathic Eye Pain Questionnaire * 5-item Dry Eye Evaluation Questionnaire (DEQ-5) * Visual Impact Assessment Questionnaire * Concise Ophthalmic Pain Questionnaire * Questionnaire to evaluate the effectiveness and tolerance of treatments * Chronic pain questionnaire
PROCEDUREBilateral ophthalmologic examination
* Examination of the ocular surface and eyelids Slit lamp with fluorescein instillation: Oxford scheme and Break-up time, Schirmer's test, Oxybuprocaine test * Lipiview® test * Examination of corneal sensitivity with the Cochet-Bonnet esthesiometer * In vivo morphological examination of the subepithelial nerve plexus of the cornea by confocal microscopy
Sponsors
Fondation Ophtalmologique Adolphe de Rothschild
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Patients previously included in the QUALVIDON study with the following characteristics: * With characteristics of idiopathic neuropathic eye pain associated with dry eye * Give informed consent * Affiliated or beneficiary of the french social security
Exclusion criteria
* Pregnant or nursing woman * Patient under legal protection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of neuropathic eye pain | at 5 years follow-up | Total score of the french neuropathic eye pain questionnaire (QDON) Range from 0 to 28. A score with higher value reflects a more severe disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Schirmer's test | at 5 years follow-up | Schirmer's test (in millimeters) |
| Assessment of Tear break up time | at 5 years follow-up | Tear break up time (in seconds) |
| Diagnosis of blepharitis | at 5 years follow-up | Diagnosis of blepharitis (none or yes: minimal/moderate/severe) |
| Assessment of Meibomian gland dysfunction | at 5 years follow-up | Meibomian gland dysfunction (none or yes: minimal/ moderate/severe) |
| Assessment of the thickness of tear film lipid Layer | at 5 years follow-up | Characterization of the thickness of the tear film lipid Layer (evaluated by Lipiview® and quantified by the device in nm) |
| Diagnosis of atrophy of the Meibomian glands | at 5 years follow-up | Diagnosis of atrophy of the Meibomian glands (evaluated by Lipiview® and rated by the device, from 0 to 4) |
| Assessment of Oxford score | at 5 years follow-up | Oxford score (range from 0 to V). Interpretation: 0= mild symptoms to V= severe symptoms. |
| Assessment of dry eye severity | at 5 years follow-up | Total score of the french version of the DEQ-5 (Dry Eye Questionnaire). Range from 0 to 22. A score with higher value reflects a more severe dryness. |
| Visual impact of dry eye | at 5 years follow-up | Total score of the french version of the OSDI (Ocular Surface Disease Index). Range from 0 to 48. A score with higher value reflects a more severe visual impact. |
| General impact of eye pain | at 5 years follow-up | Total score of the french version of the modified BPI (Brief Pain Inventory) for ophtalmology. Range from 0 to 110. A score with higher value reflects a more severe general impact of the pain. |
| Psychologic impact of eye pain | at 5 years follow-up | Total sub-scores of Anxiety (A) and depression (D) of the french version of the HAD (Hospital Anxiety and Depression Scale). Scores A (Anxiety): range from 0 to 21. Interpretation: \< or = 7: no symptom of anxiety, 8 to 10: uncertain symptomatology, \> or = 7: symptoms of anxiety Scores D (Depression): range from 0 to 21. Interpretation: \< or = 7: no symptom of depression, 8 to 10: uncertain symptomatology, \> or = 7: symptoms of depression |
| Drug effectivness (pain relief) | at 5 years follow-up | Pain relief will be assess with a likert type scale (range from 0 = none to 5 = total relief) for each drug |
| Drug safety | at 5 years follow-up | Drug safety will be assess with a likert type scale (range from 0 = none to 5 = total safety) for each drug |
| Assessment of corneal sensitivity | at 5 years follow-up | Corneal sensitivity will be assessed by the Cochet-Bonnet aesthesiometer (in millimeters) |
Countries
France
Outcome results
None listed