Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography
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:
- Group (1): Cataract will no diabetic retinopathy
- 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
- 否
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
Dina Tadros
Lecturer of Ophthalmology, Tanta University, Egypt
Tanta University
