Dry EyeQUALVIDON2NCT05523531
Prospective Single-center Long-term Follow-up Study of a Series of Cases Previously Included in the QUALVIDON Study
An observational study of Dry Eye and Neuropathic Pain, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Neuropathic Pain
- What is being tested?
- Self-administered questionnaires and Bilateral ophthalmologic examination
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2022to 6 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients previously included in the QUALVIDON study, with characteristics of idiopathic neuropathic eye pain associated with dry eye
Who may be able to join
- 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
Who cannot join
- Pregnant or nursing woman
- Patient under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Self-administered questionnaires, Bilateral ophthalmologic examination
- Keywords
- Dry eye, Neuropathic eye pain, Quality of Life
- Medical subject headings
- Dry Eye Syndromes, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered questionnairesOther
- 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 examinationProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| Patients with characteristics of idiopathic neuropathic eye pain associated with dry eye | Previously included in the QUALVIDON study Receives: Other: Self-administered questionnaires; Procedure: Bilateral ophthalmologic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 5 years follow-up
Secondary outcomes (14)
Assessment of Oxford score
Oxford score (range from 0 to V). Interpretation: 0= mild symptoms to V= severe symptoms.
Measured: at 5 years follow-up
Assessment of Schirmer's test
Schirmer's test (in millimeters)
Measured: at 5 years follow-up
Assessment of Tear break up time
Tear break up time (in seconds)
Measured: at 5 years follow-up
Diagnosis of blepharitis
Diagnosis of blepharitis (none or yes: minimal/moderate/severe)
Measured: at 5 years follow-up
Assessment of Meibomian gland dysfunction
Meibomian gland dysfunction (none or yes: minimal/ moderate/severe)
Measured: 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)
Measured: 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)
Measured: at 5 years follow-up
Assessment of corneal sensitivity
Corneal sensitivity will be assessed by the Cochet-Bonnet aesthesiometer (in millimeters)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: at 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start15 Sep 2022
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Serge DOAN, MD, Principal investigator, Hôpital Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523531
- Sponsor's protocol ID
- SDN_2022_7
- Acronym
- QUALVIDON2
- Status last verified
- Dec 2022
- First submitted
- 8 Aug 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05523531
- Acronym / sponsor ID
- QUALVIDON2 / SDN_2022_7
- Conditions
- Dry Eye, Neuropathic Pain
- Keywords
- Dry eye, Neuropathic eye pain, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with characteristics of idiopathic neuropathic eye pain associated with dry eye | – | Other: Self-administered questionnaires, Procedure: Bilateral ophthalmologic examinationPreviously included in the QUALVIDON study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients previously included in the QUALVIDON study, with characteristics of idiopathic neuropathic eye pain associated with dry eye
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant or nursing woman
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Patients with characteristics of idiopathic neuropathic eye pain associated with dry eye |
| 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 | Procedure or surgery | Patients with characteristics of idiopathic neuropathic eye pain associated with dry eye |
Primary outcome
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.
14 secondary outcomes
Assessment of Oxford score
Time frame: at 5 years follow-up
Assessment of Schirmer's test
Time frame: at 5 years follow-up
Assessment of Tear break up time
Time frame: at 5 years follow-up
Diagnosis of blepharitis
Time frame: at 5 years follow-up
Assessment of Meibomian gland dysfunction
Time frame: at 5 years follow-up
Assessment of the thickness of tear film lipid Layer
Time frame: at 5 years follow-up
Diagnosis of atrophy of the Meibomian glands
Time frame: at 5 years follow-up
Assessment of corneal sensitivity
Time frame: at 5 years follow-up
Assessment of dry eye severity
Time frame: at 5 years follow-up
Visual impact of dry eye
Time frame: at 5 years follow-up
General impact of eye pain
Time frame: at 5 years follow-up
Psychologic impact of eye pain
Time frame: at 5 years follow-up
Drug effectivness (pain relief)
Time frame: at 5 years follow-up
Drug safety
Time frame: at 5 years follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serge DOAN, MD principal investigator
Hôpital Fondation A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye and Neuropathic Pain, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of neuropathic eye pain (time frame: at 5 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.