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临床试验/CTRI/2024/02/062208
CTRI/2024/02/062208尚未招募不适用

Immediate Sequential Bilateral Cataract Surgery in Pediatric patients at a tertiary care center in India: A Retrospective Study

MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITALS1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年2月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Refractive outcome Refractive error RE and Best corrected Visual Acuity BCVA in Immediate sequential bilateral cataract surgery ISBCS in children

研究概览

简要总结

Pediatric cataract is a treatable leading cause of childhood blindness. It accounts for 7.4%–15.3% of pediatric blindness of which 60% cases are bilateral. Immediate Sequential Bilateral Cataract Surgery (ISBCS) is gaining acceptance across the globe as a result of its several medical, social and economical benefits and the safety of the procedure. Outcomes and complications of immediate versus delayed sequential bilateral cataract surgery in children can be studied and risks and benefits of the two procedures can be compared.

研究设计

研究类型
Observational

入排标准

年龄范围
6.00 Month(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Patients in the age group of 6 month to 12 years, with visually significant bilateral congenital or developmental cataract.
  • Axial length greater or equal to 17 mm in both eyes and difference between 2 eyes less than or equal to 1.5mm.

排除标准

  • Axial length more than 25mm.
  • Corneal opacities or corneal dystrophies.
  • Lens coloboma, microspherophakia, scleroderma
  • Subluxated lens, ectopia lentis
  • Coexisting glaucoma
  • Untreated blepharitis, meibomitis and dacryocystitis.
  • Complicated cataract e.g. cataract following uveitis, high myopia, hereditary retinal dystrophies like retinitis pigmentosa etc.
  • Traumatic cataracts
  • Posterior segment pathologies like RD or PHPV or colobomas etc.
  • Systemic diseases which increase the risk of infections like diabetes mellitus, collagen vascular disorders, mucopolysaccharidosis, patients on immunosuppressive drugs or suffering from immunocompromised diseases.

结局指标

主要结局

Refractive outcome Refractive error RE and Best corrected Visual Acuity BCVA in Immediate sequential bilateral cataract surgery ISBCS in children

时间窗: baseline, 3 weeks, 3 months, 6 months

次要结局

  • To evaluate the duration of hospital stay and duration of operating room occupancy(3 months)
  • To evaluate the procedural surgical and anesthetic complications in Immediate sequential bilateral cataract surgery ISBCS if any(3 months)

研究者

发起方
MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITALS
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Anju Rastogi

Maulana Azad Medical College

研究点 (1)

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