Evaluation Use Optical Coherence Tomography - Rescan During Dissection of Macular Membranes : Pre and Post Operative Aspects
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Assess optimal maneuvers in macular membrane dissection
研究概览
简要总结
In our study , the investigators will use the microscope with OCT ( Lumera with RESCAN OCT ) coupled to assess the extent , depth and change of retinal architecture in the perioperative period . Thus , they will evaluate what the optimal maneuvers of dissection of macular membranes to obtain a more satisfactory result of the rearrangement in the retinal layers . Furthermore , the use of OCT perioperative may dispense with the use of dyes , decreasing the concentration used or reduce the exposure time. Thus, they can get the potential decrease in retinal toxicity may be generated by them.
详细描述
The investigators will use the microscope with OCT (Lumera with RESCAN OCT) coupled to assess the extent, depth and change of retinal architecture in the perioperative period. Thus, they will evaluate what the optimal maneuvers of dissection of macular membranes to obtain a more satisfactory result of the rearrangement in the retinal layers. Furthermore, the use of OCT perioperative may dispense with the use of dyes, decreasing the concentration used or reduce the exposure time.
Materials and methods The investigators will evaluate 30 patients with changes in macular membranes with surgical removal of indication from the Retina and Vitreous outpatient sector of Unifesp - Paulista School of Medicine. The patients will be classified according to the diseases in the following groups: Macular Hole, Epiretinal Membrane, Traction Syndrome vitreomacular, and proliferative vitreoretinopathy of Retinal Detachment. Everyone will be informed about the risks and benefits of the study and sign an informed consent form. In the preoperative evaluation a complete ophthalmologic examination with complementary tests such as angiography and optical coherence tomography will be done.
Patients will undergo retinal surgery using the Lumera Microscope WITH RESCAN OCT - ZEISS. The team of surgeons will answer the questionnaire on the surgical difficulty regarding the identification and removal of macular membranes.
All patients will be assessed at 1, 7, 15, 30, 60 and 90 and 180 days after surgery, including the following tests:
- Measurement of visual acuity with best correction
- Previous Biomicroscopy
- Indirect Funduscopy
- tonometry
- Optical coherence tomography (OCT)
- Retinography Surgeries and procedures of the study groups will be conducted by the same team of surgeons and all surgeries and procedures will be carried out in IPEPO - Paulista Institute of Studies and Research in Ophthalmology / Vision Institute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •Visual acuity less than 20/60 in the affected eye
- •18 years of both sexes
- •1 diagnostics of the diseases Macular Hole,Epiretinal membrane,Traction Syndrome vitreomacular, vitreoretinopathy Proliferative Retina Detachment.
- •Indication of vitreoretinal surgery
排除标准
- •Any previous eye surgery in the study eye
- •Better visual acuity than or equal to 20/
- •Any previous infection affecting any eye structure. transport costs and feeding of patients will be the responsibility of the researchers.
结局指标
主要结局
Assess optimal maneuvers in macular membrane dissection
时间窗: Day 0 (surgical day)
by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
次要结局
- describe the surgical difficulty for macular membrane dissection(Day 0)
- Compare the time of surgery between groups(Day 0 (surgical day))
研究者
Michel Eid Farah
Michel Eid Farah
Federal University of São Paulo