跳至主要内容
临床试验/NCT02084212
NCT02084212终止不适用

Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2013年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
2
主要终点
Evaluation of retinal sensitivity by microperimetry

研究概览

简要总结

The aim of this research is to assess current care by studying macular function using microperimetry and by then comparing visual acuity results with OCT (Optical Coherence Tomography) data.

The examinations performed are those usually done in the follow-up of epiretinal membrane surgery, apart from microperimetry which is an examination of the central visual field. Patients who undergo ERM surgery usually have a follow-up examination at 1 month, 3 months and 6 months after the surgery. The consultation includes an assessment of visual acuity, a fundus examination an SD-OCT of the retina. The present protocol will require no additional visits. The microperimetry will be done in addition to the usual follow-up examinations after ERM surgery.

研究设计

研究类型
Interventional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persons who have provided consent,
  • Patients about to undergo idiopathic epiretinal membrane surgery,
  • Patients undergoing first-line macular surgery

排除标准

  • Persons not covered by national health insurance
  • Preexisting disease of macula/epiretinal membrane (ARMD, chorioretinal scarring)
  • Preoperative amblyopic eye
  • Insufficiently transparent media making it impossible to do the examinations

研究组 & 干预措施

Patients about to undergo epiretinal membrane surgery

Other

干预措施: Microperimetry (Other)

结局指标

主要结局

Evaluation of retinal sensitivity by microperimetry

时间窗: Up to 6 months after the operation

Change of visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) scale

时间窗: Up to 6 months after the operation.

Anomalies observed in the outer layers of retina

时间窗: Up to 6 months after the operation

次要结局

  • Abnormal surface autofluorescence(Up to 6 months after the operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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