跳至主要内容
临床试验/NCT04499768
NCT04499768Unknown不适用

A Longitudinal Study of Choroidal Changes Assessed With Swept-source Optical Coherence Tomography After Cataract Surgery in Eyes With Diabetic Retinopathy

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
46
试验地点
1
主要终点
CVI at 3 months postoperatively

研究概览

简要总结

To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery

详细描述

To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery through the follow-up of choroidal thickness (CT) and choroidal vascularity index (CVI) using swept-source optical coherence tomography (SS-OCT) system.

研究设计

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

入排标准

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

入选标准

  • aged⩾40years; intraocular pressure (IOP) < 21 mm Hg in both eyes, spherical refractive error<6 diopters spherical equivalent.

排除标准

  • previous retinal surgery, glaucoma, uveitis, age-related macular degeneration, arterial or vein occlusions, macular hole, or other ocular diseases that could interfere the CT and/or CVI measurement, severe systemic diseases, such as uncontrolled hypertension, obstructive sleep apnea, etc.

结局指标

主要结局

CVI at 3 months postoperatively

时间窗: CVI was assessed 3 months after surgery.

choroidal vascularity index (CVI)was defined as the proportion of vascular area to total circumscribed area.

VD at 1 week postoperatively

时间窗: VD of the choriocapillaris was assessed 1 week after surgery.

VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.

CVI at baseline

时间窗: CVI was assessed at baseline(within 1 week before surgery)

choroidal vascularity index(CVI) was defined as the proportion of vascular area to total circumscribed area.

CT at 3 months postoperatively

时间窗: CT was assessed at 3 months after surgery.

Choroid thickness (CT) was the thickness of the choroidal layer, CT values were obtained with the built-in software of the SS-OCT device.

VD at 1 month postoperatively

时间窗: VD of the choriocapillaris was assessed 1 month after surgery.

VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.

CT at baseline

时间窗: CT was assessed at baseline and 1 week, 1 month, 3 month after surgery.

Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.

VD at baseline

时间窗: VD of the choriocapillaris was assessed at baseline.

VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.

VD at 3 months postoperatively

时间窗: VD of the choriocapillaris was assessed 3 months after surgery.

VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid

CT at 1 week postoperatively

时间窗: CT was assessed at 1 week after surgery.

Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.

CT at 1 month postoperatively

时间窗: CT was assessed at 1 month after surgery.

Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.

CVI at 1 week postoperatively

时间窗: CVI was assessed 1 week after surgery.

choroidal vascularity index (CVI) was defined as the proportion of vascular area to total circumscribed area.

CVI at 1 month postoperatively

时间窗: CVI was assessed 1 month after surgery.

choroidal vascularity index (CVI) was defined as the proportion of vascular area to total circumscribed area.

次要结局

  • BCVA at 3 months postoperatively(BCVA was assessed 3 months after surgery.)
  • IOP at 1 week postoperatively(IOP was assessed 1 week after surgery.)
  • IOP at 3 months postoperatively(IOP was assessed 3 months after surgery.)
  • BCVA at baseline(BCVA was assessed at baseline .)
  • IOP at baseline(IOP was assessed at baseline and 1 week, 1 month, 3 month after surgery.)
  • IOP at 1 month postoperatively(IOP was assessed 1 month after surgery.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xi Shen

chief physician

Ruijin Hospital

研究点 (1)

Loading locations...

相似试验