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

Not Applicable

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

• Registration Number: NCT02081170
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-03
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-06
• Last Update Submitted: 2014-03-06
• Study First Posted: 2014-03-07
• Last Update Posted: 2014-03-07
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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)

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
autologous platelet concentrate	Autologous platelet concentrate	-

Primary Outcome Measures

Name	Time	Method
macular hole closure	6 months

Secondary Outcome Measures

Name	Time	Method
best-corrected visual acuity	6 months
metamorphopsia score	6 months
safety outcome	6 months	frequency and severity of ocular adverse event

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of