Effects of Macular Buckle Versus Vitrectomy on Macular Schisis and Macular Detachment in Highly Myopic Eyes

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Sun Yat-sen University

Status

Completed

Conditions

High Myopia
Retinoschisis
Macular Detachment

Treatments

Procedure: Vitrectomy
Procedure: Macular buckling

Study type

Interventional

Funder types

Other

Identifiers

NCT03023800
2013meky013(2)

Details and patient eligibility

About

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 schisis.

Full description

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.

Enrollment

80 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Buckle
Experimental group
Description:
Macular buckling and intraocular gas (C3F8) injection.
Treatment:
Procedure: Macular buckling
Vitrectomy
Active Comparator group
Description:
Vitrectomy, internal limiting membrane peeling, and gas tamponade (C3F8).
Treatment:
Procedure: Vitrectomy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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