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

Completed

• Conditions: Neuropathic Pain; Dry Eye
• Interventions: Other: Self-administered questionnaires; Procedure: Bilateral ophthalmologic examination

• Registration Number: NCT05523531
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-08-31
• Study Start: 2022-09-15
• Status Verified: 2022-12
• Primary Completion: 2022-12-06
• Study Completion: 2022-12-06
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with characteristics of idiopathic neuropathic eye pain associated with dry eye	Self-administered questionnaires	Previously included in the QUALVIDON study
Patients with characteristics of idiopathic neuropathic eye pain associated with dry eye	Bilateral ophthalmologic examination	Previously included in the QUALVIDON study

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Assessment of Oxford score	at 5 years follow-up	Oxford score (range from 0 to V). Interpretation: 0= mild symptoms to V= severe symptoms.
Diagnosis of blepharitis	at 5 years follow-up	Diagnosis of blepharitis (none or yes: minimal/moderate/severe)
Assessment of corneal sensitivity	at 5 years follow-up	Corneal sensitivity will be assessed by the Cochet-Bonnet aesthesiometer (in millimeters)
Assessment of Schirmer's test	at 5 years follow-up	Schirmer's test (in millimeters)
Assessment of Meibomian gland dysfunction	at 5 years follow-up	Meibomian gland dysfunction (none or yes: minimal/ moderate/severe)
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.
Assessment of Tear break up time	at 5 years follow-up	Tear break up time (in seconds)
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)
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.
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
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.
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

Trial Locations

Locations (1)

Hôpital Fondation A. de Rothschild; 🇫🇷 Paris, France