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

NCT05523531 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2022-12-08

No results posted yet for this study

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.

Conditions

  • Dry Eye
  • Neuropathic Pain

Interventions

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

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Principal Investigators

  • Serge DOAN, MD · Hôpital Fondation A. de Rothschild

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2022-12-06
Completion
2022-12-06

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05523531 on ClinicalTrials.gov