Prospective Single-center Long-term Follow-up Study of a Series of Cases Previously Included in the QUALVIDON Study

Study Overview
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Brief Summary
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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.

Official Title
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Description of Symptoms, Impact on Quality of Life, Ophthalmological Examination and Treatment of Patients With Neuropathic Eye Pain Associated With Dry Eye: a Prospective Single-center Long-term Follow-up Study of a Series of Cases Previously Included in the QUALVIDON Study

Conditions
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Dry Eye, Neuropathic Pain

Intervention / Treatment
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* Other: Self-administered questionnaires
* Procedure: Bilateral ophthalmologic examination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with characteristics of idiopathic neuropathic eye pain associated with dry eye<br>Previously included in the QUALVIDON study | Other: Self-administered questionnaires<br>* 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<br>Procedure: Bilateral ophthalmologic examination<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of neuropathic eye pain | 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. | at 5 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Oxford score | Oxford score (range from 0 to V). Interpretation: 0= mild symptoms to V= severe symptoms. | at 5 years follow-up | 
| Assessment of Schirmer's test | Schirmer's test (in millimeters) | at 5 years follow-up | 
| Assessment of Tear break up time | Tear break up time (in seconds) | at 5 years follow-up | 
| Diagnosis of blepharitis | Diagnosis of blepharitis (none or yes: minimal/moderate/severe) | at 5 years follow-up | 
| Assessment of Meibomian gland dysfunction | Meibomian gland dysfunction (none or yes: minimal/ moderate/severe) | at 5 years follow-up | 
| Assessment of the thickness of tear film lipid Layer | Characterization of the thickness of the tear film lipid Layer (evaluated by Lipiview® and quantified by the device in nm) | at 5 years follow-up | 
| Diagnosis of atrophy of the Meibomian glands | Diagnosis of atrophy of the Meibomian glands (evaluated by Lipiview® and rated by the device, from 0 to 4) | at 5 years follow-up | 
| Assessment of corneal sensitivity | Corneal sensitivity will be assessed by the Cochet-Bonnet aesthesiometer (in millimeters) | at 5 years follow-up | 
| Assessment of dry eye severity | 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. | at 5 years follow-up | 
| Visual impact of dry eye | 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. | at 5 years follow-up | 
| General impact of eye pain | 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. | at 5 years follow-up | 
| Psychologic impact of eye pain | 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 | at 5 years follow-up | 
| Drug effectivness (pain relief) | Pain relief will be assess with a likert type scale (range from 0 = none to 5 = total relief) for each drug | at 5 years follow-up | 
| Drug safety | Drug safety will be assess with a likert type scale (range from 0 = none to 5 = total safety) for each drug | at 5 years follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye, Neuropathic eye pain, Quality of Life