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临床试验/NCT01471912
NCT01471912已完成不适用

Asymmetric Elongation of Foveal Tissue After Macular Hole Surgery and Its Impact on Metamorphopsia

Samsung Medical Center2 个研究点 分布在 2 个国家目标入组 31 人开始时间: 2009年9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
31
试验地点
2
主要终点
Changes in the inter-outer plexiform layer distance

研究概览

简要总结

In our experience, elongation of foveal tissue after macular hole surgery which was undetectable by conventional time-domain optical coherence tomography was often observed on spectral-domain optical coherence tomography images. Elongation of tissues inevitably induces some degree of disorganization of tissue microstructure.

The purpose of the present study was to evaluate elongation profile of foveal tissue after macular hole surgery and to investigate its impact on visual acuity and metamorphopsia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who were diagnosed with idiopathic macular hole

排除标准

  • traumatic macular hole
  • evidence of ocular inflammation, diabetic retinopathy, hypertensive retinopathy, and retinal vasculitis, media opacity that would influence visual acuity or preclude acquisition of clear spectral domain optical coherence tomography images
  • presence of cataract judged to affect visual function, -6.0 diopters or more of spherical equivalent, prominent staphyloma
  • history of intraocular surgery other than uncomplicated cataract surgery, other ocular diseases that may influence the macular microstructure or visual function
  • patients with indistinct intraretinal structure on spectral domain optical coherence tomography images

结局指标

主要结局

Changes in the inter-outer plexiform layer distance

时间窗: first postoperative visit, 1 month, 2 months, and 6 months after macular hole surgery

the spectral domain optical coherence tomography scannings were performed at first postoperative visit, 1 month, 2 months, and 6 months after macular hole surgery. The inter-outer plexiform layer distance was measured based on optical coherence tomography images at defined time points

Changes in best-corrected visual acuity

时间窗: first postoperative visit, 2 months, and 6 months after macular hole surgery

Best-corrected visual acuity was measured using early treatment diabetic retinopathy study chart at defined time points

Changes in degree of metamorphopsia

时间窗: first postoperative visit, 2 months, and 6 months after macular hole surgery

The degree of metamorphopsia was measured using Metamorphopsia-chart at defined time points

Degree of percent asymmetric elongation on the same plane

时间窗: at 6 months postoperative

The horizontal percent asymmetry was calculated as (nasal distance - temporal distance)/(nasal distance + temporal distance). The vertical percent asymmetry was also calculated as (superior distance - inferior distance)/ (superior distance + inferior distance.

Degree of horizontal-vertical percent asymmetry

时间窗: at 6 months postoperative

The percent asymmetry was calculated as (horizontal inter-outer plexiform layer distance - vertical inter-outer plexiform layer distance)/(horizontal inter-outer plexiform layer distance + vertical inter-outer plexiform layer distance).

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 (2)

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