Macular DegenerationPISONCT06262737
Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
An observational study of Macular Degeneration and Diabetic Macular Edema, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2023to 1 Oct 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patient with retinal injury who will have 3 injections as the induction protocol (1 injection per month) for one eye and that didn't had any injection before.
Who may be able to join
- Patient with exsudative age-related macular degeneration, diabetic macular edema or retinal vein occlusion
- Patient with 3 ocular intravitreal injections of anti-VEGF in one eye
Who cannot join
- pregnant or breastfeeding woman
- intravitreal injection before the study
- intravitreal injection in both eyes
- allergy of betadine
- guardianship patient
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
About this study
The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF.
Read the detailed description
The recrutement of the patient is done during the inclusion of the patient by the nurses of the ophtalmological service of clermont-ferrand and confirm by an ophtalmologist of the service.
A mesure of the OSDI is done before the injection, then at 1 day, on week by a phone call. Each of this mesures are done for the 2 other injections.
Before each of this injection, a clinical mesure is done by a lacrydiag: the atrophy of the meibomian glands, the non-invasive break-up time, interferometry, the heigh of the tear meniscum.
- Medical subject headings
- Macular Degeneration, Retinal Vein Occlusion
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI
Ocular Surface Disease Index: 12 questions treating of either the sensation, the visual impact and the environemental impact of the dry eye disease
Measured: before the injection and at 1 day
Secondary outcomes (6)
OSDI
Ocular Surface Disease Index: 12 questions treating of either the sensation, the visual impact and the environemental impact of the dry eye disease
Measured: before the injection and at 1 week
HM
MH: hauteur méniscal : high of meniscal tear film
Measured: before each injection
AM
Atrophie meibomienne: meibomian atrophy
Measured: before each injection
NIBUT 1
First Non Invasive Break-Up Time: time when the tear film lose is regularity regardless of is location
Measured: before each injection
NIBUT 2
Average Non Invasive Break-Up Time : average time when the tear film lose is regularity for each location
Measured: before each injection
Interferometry
Interferometry: High of the lipid film of the tear
Measured: before each injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start30 Sep 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic CHIAMBARETTA, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262737
- Sponsor's protocol ID
- RBHP 2023 CHIAMBARETTA
- Other IDs
- 2023-A01121-44
- Acronym
- PISO
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
- ClinicalTrials.gov ID
- NCT06262737
- Acronym / sponsor ID
- PISO / RBHP 2023 CHIAMBARETTA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 16 Feb 2024 (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.
The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF.
Detailed description
The recrutement of the patient is done during the inclusion of the patient by the nurses of the ophtalmological service of clermont-ferrand and confirm by an ophtalmologist of the service.
A mesure of the OSDI is done before the injection, then at 1 day, on week by a phone call. Each of this mesures are done for the 2 other injections.
Before each of this injection, a clinical mesure is done by a lacrydiag: the atrophy of the meibomian glands, the non-invasive break-up time, interferometry, the heigh of the tear meniscum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with retinal injury who will have 3 injections as the induction protocol (1 injection per month) for one eye and that didn't had any injection before.
Key inclusion criteria (2 listed)
- Patient with exsudative age-related macular degeneration, diabetic macular edema or retinal vein occlusion
- Patient with 3 ocular intravitreal injections of anti-VEGF in one eye
Key exclusion criteria (5 listed)
- pregnant or breastfeeding woman
- intravitreal injection before the study
- intravitreal injection in both eyes
- allergy of betadine
- guardianship patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OSDI
Time frame: before the injection and at 1 day
Ocular Surface Disease Index: 12 questions treating of either the sensation, the visual impact and the environemental impact of the dry eye disease
6 secondary outcomes
OSDI
Time frame: before the injection and at 1 week
HM
Time frame: before each injection
AM
Time frame: before each injection
NIBUT 1
Time frame: before each injection
NIBUT 2
Time frame: before each injection
Interferometry
Time frame: before each injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
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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.
Frederic CHIAMBARETTA principal investigator
University Hospital, Clermont-Ferrand
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 Macular Degeneration and Diabetic Macular Edema, run by University Hospital, Clermont-Ferrand 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI (time frame: before the injection and at 1 day). 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 16 Feb 2024.