Skip to content

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)

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03677700
Acronym
FLAVIC
Enrollment
100
Registered
2018-09-19
Start date
2018-09-30
Completion date
2020-07-31
Last updated
2018-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation Eye

Keywords

vitrectomy, cryoindentation

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.

Interventions

OTHERLaser Flare Meter

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

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evolution of the flare valueChanges between baseline (preoperatively) and day 7, month 1, month 2, month 3, month 6, and month 12 measuresEvolution of the flare value preoperatively and then to D7, M1, M2, M3, M6, M12 of the operated eye

Secondary

MeasureTime frameDescription
Flare values of the fellow eye and the operated eyeDifference 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 12Flare value of the fellow eye and the operated eye at each evaluation time

Other

MeasureTime frameDescription
Flare value of the operated eyeChanges between baseline (preoperatively) and day 7, month 1, month 2, month 3, month 6, and month 12 measuresFlare value of the operated eye preoperatively and at each evaluation time
Criteria associated with high inflammationBaseline (preoperatively)Identification of criteria associated with high inflammation : indication of surgery

Contacts

Primary ContactDalal ASRI
dalal.asri@chu-rennes.fr299284289
Backup ContactCoralie DOUDNIKOFF
coralie.doudnikoff@chu-rennes.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026