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临床试验/NCT05138029
NCT05138029招募中3 期

Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time Optical Coherence Tomography During Operation

Affiliated Hospital of Nantong University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年11月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Review the patient's vision before surgery

研究概览

简要总结

Select Proliferative Proliferative diabetic retinopathy(PDR) patients who are planning to undergo vitrectomy for informed notification. After obtaining informed consent, vitrectomy will be performed. After hemorrhage is removed, the macular shape can be obtained through intraoperative optical coherence tomography (iOCT) real-time scanning. If the central Macular Thickness (CMT) of the patient is ≥250μm, random Enter the Anti-vascular endothelial growth factor (anti-VEGF) treatment group, the internal limiting membrane stripping group and the glucocorticoid treatment group for treatment, and compare the patients' visual acuity (1 day, 7 days, 1 month, 3 months, 6 months) and The thickness of the center of the macula, compare and observe its treatment effect.

详细描述

  1. Test method:
  • Include suitable cases of diabetic retinopathy and macular edema Inclusion criteria: a. PDR patients with severe vitreous hemorrhage who cannot collect oct images and require vitrectomy b. Type 2 diabetes, aged 18~80 years old c. Good blood sugar control (glycated hemoglobin <8.3%) d. Sign the informed consent form voluntarily, and are willing and able to follow the outpatient visits and research procedures within the time specified in the trial Exclusion criteria: a. Exclude severe infections of conjunctiva, cornea, and sclera b. Combined with other retinal vascular diseases such as retinal vein occlusion c. Cardiorenal insufficiency d. Myocardial infarction or stroke occurred within 6 months ②Intraoperative real-time operation All patients underwent 25Gauge(25G) transplanter three-channel vitrectomy to remove cloudy vitreous or vitreous hemorrhage and posterior vitreous cortex. Through intraoperative oct, the macular area was observed in real time and the central macular thickness was measured. If central macular thickness (CMT) ≥ 250 μm, anti-VEGF, glucocorticoid, or internal limiting membrane peeling was randomly selected to treat macular edema.

  • Re-examine the effect of surgery after operation The visual acuity and the thickness of the center of the macula were reviewed at 1 day, 7 days, 1 month, 3 months, and 6 months after the operation to compare the effect of the operation, and observe the cornea, anterior chamber, vitreous cavity, and intraocular pressure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

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

  • PDR patients with severe vitreous hemorrhage who cannot collect oct images and need vitrectomy
  • Type 2 diabetes, aged 18~80 years old
  • Good blood sugar control (glycated hemoglobin <8.3%)
  • Sign the informed consent form voluntarily, and are willing and able to follow the outpatient visits and research procedures within the time specified in the trial

排除标准

  • Exclude severe infections of conjunctiva, cornea, and sclera
  • Combined with other retinal vascular diseases such as retinal vein occlusion
  • Cardiorenal insufficiency
  • Myocardial infarction or stroke occurred within 6 months.

研究组 & 干预措施

Anti-VEGF treatment group

Experimental

Visual acuity and center thickness of the macula

干预措施: Ranibizumab Injection [Lucentis] (Drug)

Inner limiting membrane stripping group

Experimental

Visual acuity and center thickness of the macula

干预措施: Inner limiting membrane stripping (Procedure)

Glucocorticoid treatment group

Experimental

Visual acuity and center thickness of the macula

干预措施: Dexamethasone intravitreal implant (Drug)

结局指标

主要结局

Review the patient's vision before surgery

时间窗: The day before the patient's surgery

Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.

次要结局

  • Review the patient's vision for one day after surgery(The patient's first day after surgery)
  • Review the patient's vision for 1 month after surgery(4th week after surgery)
  • Review the patient's vision for 6 months after surgery(24th week after surgery)
  • Review the patient's vision for 7 days after surgery(1st week after surgery)
  • Review the patient's vision for 3 months after surgery(12th week after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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