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)
FLAVIC
1 other identifier
observational
100
0 countries
N/A
Brief Summary
Observational study, monocentric, prospective, descriptive and comparative (eye operated vs fellow eye).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedFirst Posted
Study publicly available on registry
September 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedSeptember 19, 2018
May 1, 2018
1.8 years
May 17, 2018
September 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evolution of the flare value
Evolution of the flare value preoperatively and then to D7, M1, M2, M3, M6, M12 of the operated eye
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
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
Other Outcomes (5)
Flare value of the operated eye
Changes between baseline (preoperatively) and day 7, month 1, month 2, month 3, month 6, and month 12 measures
Criteria associated with high inflammation
Baseline (preoperatively)
Criteria associated with high inflammation
Baseline (preoperatively)
- +2 more other outcomes
Interventions
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
Eligibility Criteria
Major patient undergoing vitrectomy or preindentation in the ophthalmology department of Rennes University Hospital
You may qualify if:
- 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
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dalal ASRI
Rennes University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2018
First Posted
September 19, 2018
Study Start
September 1, 2018
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
September 19, 2018
Record last verified: 2018-05