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临床试验/NCT04594603
NCT04594603招募中不适用

Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography

Tanta University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年4月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA

研究概览

简要总结

To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA, a comparative study between healthy and diabetic patients

详细描述

A prospective study of 30 patients with senile or complicated cataract scheduled to do phacoemulsification surgery in Tanta University Hospital

Two groups will be divided:

  1. Group (1): Cataract will no diabetic retinopathy
  2. Group (2): Cataract associated with diabetic retinopathy.

All patients will be subject to Full ophthalmologic examination before the surgery. Imaging will include OCTA. OCTA will be performed using cirrus OCT (Zeiss, Inc., USA). High-quality 6 x 6 mm OCTA macular scans and 3 × 3-mm papillary scan with strong signal-noise ratio with adequate centration on the fovea and optic nerve head respectively will be selected.

Segmentation will be used to evaluate superficial and deep capillary retinal plexus projections in addition to the choriocapillaries. If errors in segmentation were detected, manual correction would be performed. The superficial retinal capillary plexus (SCP) will be delineated with an inner boundary at the internal limiting membrane (ILM) and an outer boundary 10 µm inside the inner plexiform layer (IPL). The deep retinal capillary plexus (DCP) will be segmented with an inner boundary 10 µm inside the IPL and an outer boundary at 10 µm beneath the outer plexiform layer (OPL).

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
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Presence of a nuclear, cortical cataract or complicated cataract due to diabetic mellitus
  • Intraocular pressure (IOP) of 21 mm Hg or lower
  • Axial length (AL) between 20.0 mm and 25.0 mm.

排除标准

  • Eyes with an AL longer than 25.0 mm or shorter than 20.0 mm,
  • IOP higher than 21 mm Hg,
  • History of ocular trauma or intraocular surgery, or any abnormal intraocular findings
  • Poor OCT-A images because of severe cataracts or unstable fixation
  • Any signs of intraoperative or postoperative complications

结局指标

主要结局

To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA

时间窗: 1 week after surgery

次要结局

未报告次要终点

研究者

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

Dina Tadros

Lecturer of Ophthalmology, Tanta University, Egypt

Tanta University

研究点 (1)

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