NCT02081170UnknownNot Applicable
The Intravitreal Autologous Platelet Concentrate Injection as an Adjunct of Vitrectomy for the Treatment of Refractory Macular Holes
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Samsung Medical Center
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- macular hole closure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
autologous platelet concentrate
Experimental
Intervention: Autologous platelet concentrate (Procedure)
Outcomes
Primary Outcomes
macular hole closure
Time Frame: 6 months
Secondary Outcomes
- best-corrected visual acuity(6 months)
- metamorphopsia score(6 months)
- safety outcome(6 months)
Investigators
Study Sites (1)
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