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)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Evolution of the flare value
研究概览
简要总结
Observational study, monocentric, prospective, descriptive and comparative (eye operated vs fellow eye).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Evolution of the flare value
时间窗: 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
次要结局
- 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)