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

Dry Eye Clinical Trial

— QUALVIDON2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05523531
• Other study ID #: SDN_2022_7
• Status: Completed
• Start date: September 15, 2022
• Est. completion date: December 6, 2022

Study information

• Verified date: December 2022
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 6, 2022
• Est. primary completion date: December 6, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Neuralgia
• Neuropathic Pain

Intervention

Other:
• Self-administered questionnaires
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

Procedure:
• Bilateral 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

Locations

Country	Name	City	State
France	Hôpital Fondation A. de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

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