Inflammation EyeFLAVICNCT03677700
Evaluation of Inflammation of the Anterior Segment by Laser Flashmeter in Patients Having Undergone Surgery of the Posterior Segment (Vitrectomy or Preindentation) During the First Postoperative Year. (FLAVIC)
An observational study of Inflammation Eye, run by Rennes University Hospital.
Trial summary
Observational study, monocentric, prospective, descriptive and comparative (eye operated vs fellow eye). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation Eye
- What is being tested?
- Laser Flare Meter
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Jul 2020
- 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: Major patient undergoing vitrectomy or preindentation in the ophthalmology department of Rennes University Hospital
Who may be able to join
- Major patient,
- Operation of vitrectomy or preindentation in the ophthalmology department of Rennes University Hospital for one of the following reasons:
- Retinal detachment, rhegmatogenous or not
- Combined surgery
- Membrane peeling
- Macular hole
Show all 9Show fewer
- Optically targeted vitrectomy (Terson's syndrome, intravitreous haemorrhage)
- Covered by a health insurance system,
- Having received information on the protocol and not having expressed opposition to participating in the study
Who cannot join
- Vitrectomy for endophthalmitis or posterior uveitis,
- Patient with vitreoretinal proliferation (grade B and C),
- Pregnant or nursing woman,
- Major patient subject to legal protection (safeguard of justice, guardianship, guardianship), person deprived of liberty.
Trial locations and contacts
No sites are listed yet.
Coralie DOUDNIKOFF contact
About this study
Observational study, monocentric, prospective, descriptive and comparative (eye operated vs fellow eye).
Read the detailed description
After surgery by vitrectomy or preindentation, an anti-inflammatory treatment is conventionally prescribed for a duration of 1 month. However, frequently, during the post-operative control at one month, there may be signs of ocular inflammation or symptoms of discomfort justifying the prolongation of post-operative treatment. A 2012 study evaluated post-operative flare follow-up in 22 vitrectomized patients for retinal detachment, and showed a significantly higher flare 3 months after surgery, compared to the other eye and pre-surgery value.
In this study, the investigators wish to study postoperative inflammation in patients operated for posterior segment ocular surgery (vitrectomy or preindentation) measured by laser flashmeter on a follow-up of one year.
- Conditions
- Inflammation Eye
- Being tested
- Laser Flare Meter
- Keywords
- vitrectomy, cryoindentation
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Flare MeterOther
Measurement of the inflammation of the operated eye and the fellow eye before the surgery and at each post-surgery visit: D7, M1, M2, M3, M6, M12
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the flare value
Evolution of the flare value preoperatively and then to D7, M1, M2, M3, M6, M12 of the operated eye
Measured: Changes between baseline (preoperatively) and day 7, month 1, month 2, month 3, month 6, and month 12 measures
Secondary outcomes (1)
Flare values of the fellow eye and the operated eye
Flare value of the fellow eye and the operated eye at each evaluation time
Measured: Difference between flare values of the fellow eye and the operated eye at each evaluation time : baseline (preoperatively), day 7, month 1, month 2, month 3, month 6, and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study startSep 2018 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammation EyeStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dalal ASRI, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677700
- Sponsor's protocol ID
- 35RC18_3043_FLAVIC
- Acronym
- FLAVIC
- Status last verified
- May 2018
- First submitted
- 17 May 2018
- Last updated
- 19 Sep 2018
- 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 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Inflammation of the Anterior Segment by Laser Flashmeter in Patients Having Undergone Surgery of the Posterior Segment (Vitrectomy or Preindentation) During the First Postoperative Year. (FLAVIC)
- ClinicalTrials.gov ID
- NCT03677700
- Acronym / sponsor ID
- FLAVIC / 35RC18_3043_FLAVIC
- Conditions
- Inflammation Eye
- Keywords
- vitrectomy, cryoindentation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 19 Sep 2018 (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.
Observational study, monocentric, prospective, descriptive and comparative (eye operated vs fellow eye).
Detailed description
After surgery by vitrectomy or preindentation, an anti-inflammatory treatment is conventionally prescribed for a duration of 1 month. However, frequently, during the post-operative control at one month, there may be signs of ocular inflammation or symptoms of discomfort justifying the prolongation of post-operative treatment. A 2012 study evaluated post-operative flare follow-up in 22 vitrectomized patients for retinal detachment, and showed a significantly higher flare 3 months after surgery, compared to the other eye and pre-surgery value.
In this study, the investigators wish to study postoperative inflammation in patients operated for posterior segment ocular surgery (vitrectomy or preindentation) measured by laser flashmeter on a follow-up of one year.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patient undergoing vitrectomy or preindentation in the ophthalmology department of Rennes University Hospital
Key inclusion criteria (9 listed)
- Major patient,
- Operation of vitrectomy or preindentation in the ophthalmology department of Rennes University Hospital for one of the following reasons:
- Retinal detachment, rhegmatogenous or not
- Combined surgery
- Membrane peeling
Key exclusion criteria (4 listed)
- Vitrectomy for endophthalmitis or posterior uveitis,
- Patient with vitreoretinal proliferation (grade B and C),
- Pregnant or nursing woman,
- Major patient subject to legal protection (safeguard of justice, guardianship, guardianship), person deprived of liberty.
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 |
|---|---|---|
| Laser Flare MeterMeasurement of the inflammation of the operated eye and the fellow eye before the surgery and at each post-surgery visit: D7, M1, M2, M3, M6, M12 | Other | – |
Primary outcome
Evolution of the flare value
Time frame: Changes between baseline (preoperatively) and day 7, month 1, month 2, month 3, month 6, and month 12 measures
Evolution of the flare value preoperatively and then to D7, M1, M2, M3, M6, M12 of the operated eye
1 secondary outcome
Flare values of the fellow eye and the operated eye
Time frame: Difference between flare values of the fellow eye and the operated eye at each evaluation time : baseline (preoperatively), day 7, month 1, month 2, month 3, month 6, and month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
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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.
Coralie DOUDNIKOFF contact
Dalal ASRI principal investigator
Rennes University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation Eye, run by Rennes University Hospital.
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 9 inclusion and 4 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 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Dalal ASRI (299284289 ext. +33, dalal.asri@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the flare value (time frame: Changes between baseline (preoperatively) and day 7, month 1, month 2, month 3, month 6, and month 12 measures). 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 19 Sep 2018.