Optical Coherence Tomography Angiography Changes Post-cataract Surgery in Patients With and Without Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Change from baseline of retinal vessel density up to 3 months post-cataract surgery.
研究概览
简要总结
The purpose of this study is to use optical coherence tomography angiography (OCT-A) to compare retinal vasculature after uncomplicated cataract surgery in patients with and without diabetic retinopathy.
详细描述
Patients undergoing cataract surgery who provided informed consent were enrolled in the study. There were three comparison groups: control, diabetic retinopathy (DR) and diabetic macular edema (DME) groups. Optical coherence tomography angiography (OCT-A) scans measuring retinal thickness, vessel density, perfusion density, and foveal avascular zone were obtained at baseline and postoperative week one, month one and month three.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients at Uptown Eye Specialists undergoing uneventful cataract surgery who have provided informed consent to the study.
排除标准
- •Other ocular co-morbidities such as axial length < 22.0 mm or > 25.0 mm, previous ocular surgeries, previous history of uveitis, previous ocular trauma, cornea pathologies or glaucoma, intraocular pressures over 22 mmHg
- •In groups 1 and 2: previous retinal laser treatments
- •OCT-A signal strength < 6
- •Use of multifocal intraocular lens
- •Second eye (if first eye recruited)
- •In Group 1: No diabetes mellitus as past medical history
结局指标
主要结局
Change from baseline of retinal vessel density up to 3 months post-cataract surgery.
时间窗: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
Optical coherence tomography angiography (OCT-A) scans will be taken at baseline and postoperative week one, month one, and month three. This imaging modality provides measurements for retinal vessel density to be compared between groups and time.
Change from baseline of foveal avascular zone up to 3 months post-cataract surgery.
时间窗: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
Optical coherence tomography angiography (OCT-A) scans will be taken at baseline and postoperative week one, month one, and month three. This imaging modality provides measurements for foveal avascular zone (FAZ), particularly FAZ area, perimeter, and circularity index, to be compared between groups and time.
Change from baseline of retinal perfusion density up to 3 months post-cataract surgery.
时间窗: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
Optical coherence tomography angiography (OCT-A) scans will be taken at baseline and postoperative week one, month one, and month three. This imaging modality provides measurements for retinal perfusion density to be compared between groups and time.
Change from baseline of retinal thickness up to 3 months post-cataract surgery.
时间窗: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
Optical coherence tomography (OCT) scans will be taken at baseline and postoperative week one, month one, and month three. This imaging modality provides measurements of retinal thickness, particularly, central subfield and average macular cube thickness, to be compared between groups and time.
次要结局
- Development of new cystoid macular edema(Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months))