QUALVIDON2
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
Sponsor study identifier
observational
14
1 country
1
Study Start
September 15, 2022
Actual (reported)Primary Completion
December 6, 2022
Actual (reported)Study Completion
December 6, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 6, 2022
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 8, 2022
Actual (reported)August 31, 2022
Actual (reported)September 15, 2022
Actual (reported)December 6, 2022
Actual (reported)December 6, 2022
Actual (reported)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
Assessment of Oxford score
at 5 years follow-up
Assessment of Schirmer's test
at 5 years follow-up
Assessment of Tear break up time
at 5 years follow-up
Diagnosis of blepharitis
at 5 years follow-up
Assessment of Meibomian gland dysfunction
at 5 years follow-up
Previously included in the QUALVIDON study
* 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
Patients previously included in the QUALVIDON study, with characteristics of idiopathic neuropathic eye pain associated with dry eye
Hôpital Fondation A. de Rothschild
Paris, 75019, France
Serge DOAN, MD
Hôpital Fondation A. de Rothschild
14 participants (actual enrollment reported by the registry).
First Submitted
August 8, 2022
First Posted
August 31, 2022
Study Start
September 15, 2022
Actual (reported)The Beijing Adult Dry Eye Cohort Study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 6, 2022
Actual (reported)Study Completion
December 6, 2022
Actual (reported)Last Updated
December 8, 2022
Record last verified: 2022-12
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Source: ClinicalTrials.gov.
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