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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Neuropathic Pain
• Intervention / Treatment: Other: Self-administered questionnaires; Procedure: Bilateral ophthalmologic examination

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Hôpital Fondation A. de Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with characteristics of idiopathic neuropathic eye pain associated with dry eye; Previously included in the QUALVIDON study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Serge DOAN, MD, Hôpital Fondation A. de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): December 6, 2022
• Study Completion (Actual): December 6, 2022

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Quality of Life; Dry eye; Neuropathic eye pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Neuralgia; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: SDN_2022_7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No