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Completed

NCT Number: NCT05523531

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Fondation A. de Rothschild

Paris, 75019, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Assessment of neuropathic eye pain

    Time frame: at 5 years follow-up

    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.

Secondary outcomes

  1. Assessment of Oxford score

    Time frame: at 5 years follow-up

    Oxford score (range from 0 to V). Interpretation: 0= mild symptoms to V= severe symptoms.

  2. Assessment of Schirmer's test

    Time frame: at 5 years follow-up

    Schirmer's test (in millimeters)

  3. Assessment of Tear break up time

    Time frame: at 5 years follow-up

    Tear break up time (in seconds)

  4. Diagnosis of blepharitis

    Time frame: at 5 years follow-up

    Diagnosis of blepharitis (none or yes: minimal/moderate/severe)

  5. Assessment of Meibomian gland dysfunction

    Time frame: at 5 years follow-up

    Meibomian gland dysfunction (none or yes: minimal/ moderate/severe)

  6. Assessment of the thickness of tear film lipid Layer

    Time frame: at 5 years follow-up

    Characterization of the thickness of the tear film lipid Layer (evaluated by Lipiview® and quantified by the device in nm)

  7. Diagnosis of atrophy of the Meibomian glands

    Time frame: at 5 years follow-up

    Diagnosis of atrophy of the Meibomian glands (evaluated by Lipiview® and rated by the device, from 0 to 4)

  8. Assessment of corneal sensitivity

    Time frame: at 5 years follow-up

    Corneal sensitivity will be assessed by the Cochet-Bonnet aesthesiometer (in millimeters)

  9. Assessment of dry eye severity

    Time frame: at 5 years follow-up

    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.

  10. Visual impact of dry eye

    Time frame: at 5 years follow-up

    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.

  11. General impact of eye pain

    Time frame: at 5 years follow-up

    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.

  12. Psychologic impact of eye pain

    Time frame: at 5 years follow-up

    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

  13. Drug effectivness (pain relief)

    Time frame: at 5 years follow-up

    Pain relief will be assess with a likert type scale (range from 0 = "none" to 5 = "total relief") for each drug

  14. Drug safety

    Time frame: at 5 years follow-up

    Drug safety will be assess with a likert type scale (range from 0 = "none" to 5 = "total safety") for each drug

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study 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

Acronym: QUALVIDON2

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 31, 2022
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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