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临床试验/NCT03902795
NCT03902795已完成不适用

Functional and Morphological Results of macula-on and Macula-off Rhegmatogenous Retinal Detachment Treated With Pars Plana Vitrectomy and Sulfur Hexafluoride Gas Tamponade

Medical University of Lublin1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
M-charts

研究概览

简要总结

To examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.

详细描述

Background:

To examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.

Methods:

The study included 62 eyes that underwent successful PPV with SF6 tamponade with macula-on (34 eyes) and macula-off (28 eyes) RRD preoperatively. The best-corrected visual acuity (BCVA), Amsler test, M-charts, optical coherence tomography (OCT) and microperimetry were performed at 1, 3 and 6 months postoperatively.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • The diagnosed macula-on and macula-off rhegmatogenous retinal detachment.

排除标准

  • history of uveitis,
  • diabetic retinopathy,
  • previous vitreoretinal surgery,
  • glaucoma or eye trauma,
  • retinal detachment combined with macular hole or proliferative vitreoretinopathy

结局指标

主要结局

M-charts

时间窗: 1 to 6 months

The M-charts consist of 19 dashed lines with increasing distance between points in the range of 0.2 ° to 2.0 ° viewing angle. Matsumoto developed M-charts for quantitative metamorphopsia evaluation in macula diseases in 1990. M-charts provide more information than Amsler chart in regard to the horizontal and vertical lines.

The best-corrected visual acuity (BCVA)

时间窗: 1 to 6 months

Acuity is a measure of visual performance. The eye exam seeks to find the prescription that will provide the best corrected visual performance achievable.

Amsler test

时间窗: 1 to 6 months

The standard Amsler test performs with black lines on the white background. The Amsler grid has been used so far for the qualitative assessment of the metamorphopsia since 1947.

Central retinal thickness

时间窗: 1 to 6 months

Quantitative thickness measurements derived from the "fast macular scan" algorithm report retinal thickness at several locations including the center point, central subfield, and 4 inner and 4 outer zones of the macula.

Microperimetry

时间窗: 1 to 6 months

Microperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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