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
Conditions
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.
Interventions
PROCEDUREAutologous platelet concentrate
1. pars plana vitrectomy 2. internal limiting membrane removal 3. Fluid-air exchange 4. Intravitreal autologous platelet concentrate injection 5. Intravitreal gas (14% C3F8) injection 6. Keep prone position for 7-14 days after surgery
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| macular hole closure | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| best-corrected visual acuity | 6 months | — |
| metamorphopsia score | 6 months | — |
| safety outcome | 6 months | frequency and severity of ocular adverse event |
Countries
South Korea
Contacts
Primary ContactGa Eun Cho, MD
Outcome results
None listed