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)

• Conditions: Inflammation Eye

• Registration Number: NCT03677700
• Lead Sponsor: 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.

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-17
• Study Start: 2018-09
• Study First Submitted QC: 2018-09-17
• Last Update Submitted: 2018-09-17
• Study First Posted: 2018-09-19
• Last Update Posted: 2018-09-19
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evolution of the flare value	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

Secondary Outcome Measures

Name	Time	Method
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	Flare value of the fellow eye and the operated eye at each evaluation time