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临床试验/KCT0002686
KCT0002686招募中未知

Therapeutic Efficacy of Autologous Platelet Concentrate on Macular hole with High myopia, Large Macular Hole or Recurrent Macular Hole ; Randomized clinical trial

ational Evidence-based Healthcare Callaborating Agency0 个研究点目标入组 194 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
194

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional Study

入排标准

年龄范围
20(Year) 至 o Limit(—)
性别
All

入选标准

  • Patients who were diagnosed as full-thickness macular hole by optical coherence tomography with visual acuity of affected eye under 20/50 were included. All subject had to meet at least one of the following conditions.
  • 1) macular hole over 400µmof minimum size
  • 2) macular hole at high myopic eye (spherical equivalent over -6.0 diopters, or axial length over 25.5 millimeters)
  • 3) relapsed of recurrent macular hole

排除标准

  • Patients with any following condition were excluded.
  • 1. Pregnancy
  • 2. History of retinal detachment, or proliferative vitreoretinopathy in affected eye
  • 3. History of vitreoretinal surgery for the ocular disease other than macular hole
  • 4. Proliferative diabetic retinopathy, vitreous hemorrhage, retinal vascular obstruction, uveitis, trauma, optic nerve atrophy, intraocular tumor, or visually significant corneal opacity in affected eye
  • 5. Confirmed or suspicious intraocular/periocular infection
  • 6. Uncontrolled high Intraocular pressure (over 21 mmHg) with maximal tolerant medical treatment, or history of glaucoma surgery
  • 7. Contraindications for using autologous platelet concentrate (thrombocytopenia,any type of thromboasthenia, positive serology of hepatitis B, C, or human immunodeficiency virus, positive serology of syphilis)
  • 8. Hemodynamic instability
  • 9. Septicemia
  • 10. Event of fever, or active infectious disease within two weeks
  • 11. Cancer without complete remission, treatment history of cancer or within a year
  • 12. Alcoholism or other psychiatric disease which could have a significant effect on this study
  • 13. Bleeding tendency by long-term administration of anti-platelet or anti-coagulant agents (the patients who stop the medication for recommended wash-out period could be included)
  • 14. Administration of other drugs for clinical trial within 30 days

研究者

发起方
ational Evidence-based Healthcare Callaborating Agency

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