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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with characteristics of idiopathic neuropathic eye pain associated with dry eye | Previously included in the QUALVIDON study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-administered questionnaires | Other |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients previously included in the QUALVIDON study, with characteristics of idiopathic neuropathic eye pain associated with dry eye
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| Name | Affiliation | Role |
|---|---|---|
| Serge DOAN, MD | Hôpital Fondation A. de Rothschild | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Fondation A. de Rothschild | Paris | 75019 | France |
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|
| Bilateral ophthalmologic examination | Procedure |
|
|
| 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 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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