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临床试验/NCT04957459
NCT04957459Unknown不适用

Prospective, Observational,Non-interventional Research of The Correlation of Preoperative Measurement Parameter on the Predicting of Visual Outcomes Among Patients With Idiopathic Macular Holes

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
FAZ area of macular hole at 5 months

研究概览

简要总结

This study retrospectively analyzed the relationship between the preoperative optical coherence tomography(OCT) and optical coherence tomography angiography(OCTA) software related parameters of patients with idiopathic macular hole, the patient's own clinical data and the best corrected visual acuity (BCVA) for at least one month after surgery.

详细描述

After Pars plana vitrectomy combined with removal of the internal limiting membrane (ILM) and air filling, it can not only promote the closure of the macular hole in patients with idiopathic macular hole, but also improve the visual acuity of the affected eye. There are various studies to predict the visual acuity of patients after surgery recovery, but due to many factors that affect the effect of macular hole surgery, the improvement of visual acuity after retinal surgery varies greatly in different eyes. As a new type of ophthalmology device, OCTA plays an important role in measuring the size of the hole and the changes of retinal capillaries. Therefore, this study intends to calculate patient parameters based on OCT and OCTA equipment. Statistical software was used to analyze the relationship between each parameter and the best corrected visual acuity (BCVA) for at least one month after surgery.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • idiopathic MHs, the MH is closed ,and follow-up for at least 1 month after vitrectomy.

排除标准

  • High myopia (≥6 diopters,AL≥26.5mm), increased intraocular pressure (IOP, >21 mm Hg) or glaucoma, severe cataract, severe corneal disease,severe systemic conditions that prevent surgery, and history of ocular trauma, intraocular inflammation, retinal vascular disease, or previous ocular surgery

结局指标

主要结局

FAZ area of macular hole at 5 months

时间窗: at 5 months after surgery

Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography

CRT of macular hole

时间窗: Before surgery

Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography

Macular hole status

时间窗: at 1 month after surgery

macular hole status (open, flat open or closed)

MLD of macular hole

时间窗: Before surgery

Calculation of minimum liner diameter of macular hole with optical coherence tomography angiography

best-corrected visual acuity at 4 months

时间窗: at 4 months after surgery

best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis

CRT of macular hole at 4 months

时间窗: at 4 months after surgery

Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography

Horizontal ellipsoid band missing diameter of macular hole

时间窗: Before surgery

Calculation of Horizontal ellipsoid band missing diameter of macular hole with optical coherence tomography angiography

best-corrected visual acuity at 3 months

时间窗: at 3 months after surgery

best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis

best-corrected visual acuity at 5 months

时间窗: at 5 months after surgery

best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis

FAZ area of macular hole at 4 months

时间窗: at 4 months after surgery

Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography

CRT of macular hole at 5 months

时间窗: at 5 months after surgery

Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography

best-corrected visual acuity at 6 months

时间窗: at 6 months after surgery

best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis

FAZ area of macular hole at 1 month

时间窗: at 1 month after surgery

Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography

FAZ area of macular hole at 6 months

时间窗: at 6 months after surgery

Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography

CRT of macular hole at 1 month

时间窗: at 1 month after surgery

Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography

Choroidal hypertransmission width of macular hole

时间窗: Before surgery

Calculation of Choroidal hypertransmission width of macular hole with optical coherence tomography angiography

Baseline best-corrected visual acuity

时间窗: Before surgery

best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis

best-corrected visual acuity at 1 month

时间窗: at 1 month after surgery

best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis

FAZ area of macular hole

时间窗: Before surgery

Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography

BD of macular hole

时间窗: Before surgery

Calculation of base diameter of macular hole with optical coherence tomography angiography

best-corrected visual acuity at 2 months

时间窗: at 2 months after surgery

best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis

FAZ area of macular hole at 2 months

时间窗: at 2 months after surgery

Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography

FAZ area of macular hole at 3 months

时间窗: at 3 months after surgery

Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography

CRT of macular hole at 2 months

时间窗: at 2 months after surgery

Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography

CRT of macular hole at 3 months

时间窗: at 3 months after surgery

Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography

CRT of macular hole at 6 months

时间窗: at 6 months after surgery

Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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