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临床试验/CTRI/2022/08/044623
CTRI/2022/08/044623尚未招募未知

Outcomes of early vitrectomy for vitreous hemeorrhage secondary to proliferative diabetic retinopathy - A prospective study

Sankara eye hospital Guntur0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Age ââ?°Â¥ 18 years
  • 2. Diagnosis of diabetes mellitus (type 1 or type 2).Ã?Â
  • 3. Vitreous haemorrhage (VH) in a patient with Proliferative Diabetic Retinopathy (PDR) causing vision impairment of duration less than one month, for which intervention is deemed necessary.
  • 4. Patients who are willing and able to undergo vitrectomy within 2 weeks of presentation.
  • 5. Visual acuity ranging between PL and ETDRS logMAR 0.3 (Snellenââ?¬•s equivalent of 20/40 or 6/12).

排除标准

  • 1. Any condition that precludes the participant from undergoing elective vitrectomy surgery in the study(e.g., unstable medical status including chronic renal failure requiring dialysis, blood pressure > 180/110, cardiovascular disease, pregnancy or lactation).
  • 2. Systemic anti-VEGF or pro-vascular endothelial growth factor treatment within 4 months, intravitreal anti-VEGF in the study eye within 2 months of current vitreous haemorrhage onset, or intraocular corticosteroid treatment in the study eye within 4 months of current vitreous haemorrhage onset.
  • 3. Participation in an investigational trial within 30 days that involves any drug that has not received regulatory approval for the indication being studied.Ã?Â
  • 4. Potential participant is expected to lose follow-ups due to various reasons.
  • 5. Evidence of traction or rhegmatogenous retinal detachment involving or threatening the macula. If the density of the haemorrhage precludes a visual assessment on the clinical exam to confirm eligibility, then it is recommended that the assessment be performed with ultrasound as standard care.
  • 6. Evidence of uncontrolled glaucoma.
  • 7. History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, YAG capsulotomy etc.) within 4 months or major ocular surgery other than vitrectomy anticipated within the next 6 months in the study eye.
  • 8. Aphakia.
  • 9. The evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.

研究者

发起方
Sankara eye hospital Guntur

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