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.
Study Type
OBSERVATIONAL
Enrollment
14
* 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
* 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
Hôpital Fondation A. de Rothschild
Paris, France
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.
Time frame: at 5 years follow-up
Assessment of Oxford score
Oxford score (range from 0 to V). Interpretation: 0= mild symptoms to V= severe symptoms.
Time frame: at 5 years follow-up
Assessment of Schirmer's test
Schirmer's test (in millimeters)
Time frame: at 5 years follow-up
Assessment of Tear break up time
Tear break up time (in seconds)
Time frame: at 5 years follow-up
Diagnosis of blepharitis
Diagnosis of blepharitis (none or yes: minimal/moderate/severe)
Time frame: at 5 years follow-up
Assessment of Meibomian gland dysfunction
Meibomian gland dysfunction (none or yes: minimal/ moderate/severe)
Time frame: 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)
Time frame: 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)
Time frame: at 5 years follow-up
Assessment of corneal sensitivity
Corneal sensitivity will be assessed by the Cochet-Bonnet aesthesiometer (in millimeters)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at 5 years follow-up
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