Clinical trial NCT05523531: Prospective Single-center Long-term Follow-up Study of a Series of Cases Previously Included in the QUALVIDON Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Neuropathic Pain
Keywords: Dry eye
Neuropathic eye pain
Quality of Life
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2022-08-31
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients previously included in the QUALVIDON study, with characteristics of idiopathic neuropathic eye pain associated with dry eye

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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of neuropathic eye pain
timeFrame: at 5 years follow-up
Secondary outcomes:
measure: Assessment of Oxford score
timeFrame: at 5 years follow-up
measure: Assessment of Schirmer's test
timeFrame: at 5 years follow-up
measure: Assessment of Tear break up time
timeFrame: at 5 years follow-up
measure: Diagnosis of blepharitis
timeFrame: at 5 years follow-up
measure: Assessment of Meibomian gland dysfunction
timeFrame: at 5 years follow-up
measure: Assessment of the thickness of tear film lipid Layer
timeFrame: at 5 years follow-up
measure: Diagnosis of atrophy of the Meibomian glands
timeFrame: at 5 years follow-up
measure: Assessment of corneal sensitivity
timeFrame: at 5 years follow-up
measure: Assessment of dry eye severity
timeFrame: at 5 years follow-up
measure: Visual impact of dry eye
timeFrame: at 5 years follow-up
measure: General impact of eye pain
timeFrame: at 5 years follow-up
measure: Psychologic impact of eye pain
timeFrame: at 5 years follow-up
measure: Drug effectivness (pain relief)
timeFrame: at 5 years follow-up
measure: Drug safety
timeFrame: at 5 years follow-up
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation A. de Rothschild
Study officials:
affiliation: Hôpital Fondation A. de Rothschild
name: Serge DOAN, MD
role: PRINCIPAL_INVESTIGATOR
References: