Clinical trial NCT03677700: 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)
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammation Eye
Keywords: vitrectomy
cryoindentation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major patient undergoing vitrectomy or preindentation in the ophthalmology department of Rennes University Hospital

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Evolution of the flare value
timeFrame: Changes between baseline (preoperatively) and day 7, month 1, month 2, month 3, month 6, and month 12 measures
Secondary outcomes:
measure: Flare values of the fellow eye and the operated eye
timeFrame: 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:
measure: Flare value of the operated eye
timeFrame: Changes between baseline (preoperatively) and day 7, month 1, month 2, month 3, month 6, and month 12 measures
measure: Criteria associated with high inflammation
timeFrame: Baseline (preoperatively)
measure: Criteria associated with high inflammation
timeFrame: Baseline (preoperatively)
measure: Criteria associated with high inflammation
timeFrame: Baseline (preoperatively)
measure: Criteria associated with high inflammation
timeFrame: Baseline (preoperatively)
Locations:
Study officials:
affiliation: Rennes University Hospital
name: Dalal ASRI
role: PRINCIPAL_INVESTIGATOR
References: