The Intravitreal Autologous Platelet Concentrate Injection as an Adjunct of Vitrectomy for the Treatment of Refractory Macular Holes

Samsung Medical Center

Status: Unknown

Conditions: Recurred or Failed Macular Hole From Previous Surgery; Large Size Macular Hole (Diameter > 600 Microns) or; or Chronic Macular Hole (Symptom Duration > 6 Months); Macular Hole With High Myopia (Spherical Equivalent ≤ -6.0 Diopters) or,

Treatments: Procedure: Autologous platelet concentrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02081170

2013-12-066

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness of intravitreal autologous platelet concentrate (APC) injection during the surgery for refractory macular holes.

Enrollment: 16 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Macular hole with any of following condition

  • High myopia (spherical equivalent ≤ -6.0 Diopters)
  • Large size macular hole (Diameter > 600 microns)
  • Recurred or failed macular hole from previous surgery
  • Chronic macular hole (symptom duration > 6 months)

Exclusion criteria

• Systemic infection
• Hematologic disease
• Severe maculopathy including severe diabetic retinopathy, advanced age-related macular degeneration

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

autologous platelet concentrate

Experimental group

Treatment:

Procedure: Autologous platelet concentrate