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

Large Size Macular Hole (Diameter > 600 Microns) or Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02081170
• Other study ID #: 2013-12-066
• Status: Recruiting
• Phase: N/A
• First received: March 5, 2014
• Last updated: March 6, 2014
• Start date: December 2013

Study information

• Verified date: March 2014
• Source: Samsung Medical Center
• Contact: Ga Eun Cho, MD
• Phone: +82-3410-3548
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Large Size Macular Hole (Diameter > 600 Microns) or
• Macular Hole With High Myopia (Spherical Equivalent = -6.0 Diopters) or,
• or Chronic Macular Hole (Symptom Duration > 6 Months)
• Recurred or Failed Macular Hole From Previous Surgery
• Retinal Perforations

Intervention

Procedure:
• Autologous platelet concentrate
pars plana vitrectomy internal limiting membrane removal Fluid-air exchange Intravitreal autologous platelet concentrate injection Intravitreal gas (14% C3F8) injection Keep prone position for 7-14 days after surgery

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	macular hole closure		6 months	No
Secondary	best-corrected visual acuity		6 months	No
Secondary	metamorphopsia score		6 months	No
Secondary	safety outcome	frequency and severity of ocular adverse event	6 months	Yes