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A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy + Internal Limiting Membrane Peeling + Gas Tamponade on Macular Schisis and Concurrent Macular Detachment in Eyes With Highly Myopia (NCT03023800)

Macular schisis associated with macular detachment is a one of the complications of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal detachment associated with macular hole.
  • Procedure: Macular buckling
    Surgical procedures of macular buckling, drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis, and inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous body through pars plana, under systemic anesthesia.
    • Procedure: Vitrectomy
      Surgical procedures of small gauge vitrectomy, internal limiting membrane peeling, and gas (C3F8, 14%) tamponage, under local or systemic anesthesia
      Ages eligible for Study
      18 Years to 70 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter
      • macular schisis
      • macular retinal detachment
      • evidence of posterior staphyloma on clinical examination
      Exclusion Criteria:
      • severe macular scar
      • macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
      • prominent vitreomacular traction
      • a history of vitrectomy or macular buckle
      • intraocular active hemorrhage or inflammation
      • any media opacity which precluded imaging or clinical evaluation of the macula
      A randomized, open label, single center study comparing the efficacy of macular muckle + gas injection versus internal limiting membrane peeling + gas tamponade on macular schisis associated with macular detachment in eyes with high myopia.

      1 locations

      China (1)
      • Zhongshan Ophthalmic Center
        Not specified
        Guangzhou, Guangdong, China, 510060
      Status:
      active not recruiting
      Type:
      Interventional
      Phase:
      -
      Start:
      31 March, 2015
      Updated:
      14 August, 2017
      Participants:
      80
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