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

NCT05523531 | Completed

• 1 other identifier: SDN_2022_7
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye; Neuropathic Pain

Keywords

Dry eye; Neuropathic eye pain; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

Study Arms (1)

Patients with characteristics of idiopathic neuropathic eye pain associated with dry eye

Previously included in the QUALVIDON study

Other: Self-administered questionnaires; Procedure: Bilateral ophthalmologic examination

Interventions

Self-administered questionnaires OTHER

* 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

Patients with characteristics of idiopathic neuropathic eye pain associated with dry eye

Bilateral ophthalmologic examination PROCEDURE

* 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 with characteristics of idiopathic neuropathic eye pain associated with dry eye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Pregnant or nursing woman
• Patient under legal protection

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation A. de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Neuralgia

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Serge DOAN, MD

  Hôpital Fondation A. de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 31, 2022
• Study Start: September 15, 2022
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

FR (1)