None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : A control group underwent a regular procedure of macular hole surgery including pars plana vitrectomy with posterior vitreous detachment induction, internal limi
Sponsors
National Evidence-based Healthcare Callaborating Agency
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who were diagnosed as full-thickness macular hole by optical coherence tomography with visual acuity of affected eye under 20/50 were included. All subject had to meet at least one of the following conditions. 1) macular hole over 400µmof minimum size 2) macular hole at high myopic eye (spherical equivalent over -6.0 diopters, or axial length over 25.5 millimeters) 3) relapsed of recurrent macular hole
Exclusion criteria
Exclusion criteria: Patients with any following condition were excluded. 1. Pregnancy 2. History of retinal detachment, or proliferative vitreoretinopathy in affected eye 3. History of vitreoretinal surgery for the ocular disease other than macular hole 4. Proliferative diabetic retinopathy, vitreous hemorrhage, retinal vascular obstruction, uveitis, trauma, optic nerve atrophy, intraocular tumor, or visually significant corneal opacity in affected eye 5. Confirmed or suspicious intraocular/periocular infection 6. Uncontrolled high Intraocular pressure (over 21 mmHg) with maximal tolerant medical treatment, or history of glaucoma surgery 7. Contraindications for using autologous platelet concentrate (thrombocytopenia,any type of thromboasthenia, positive serology of hepatitis B, C, or human immunodeficiency virus, positive serology of syphilis) 8. Hemodynamic instability 9. Septicemia 10. Event of fever, or active infectious disease within two weeks 11. Cancer without complete remission, treatment history of cancer or within a year 12. Alcoholism or other psychiatric disease which could have a significant effect on this study 13. Bleeding tendency by long-term administration of anti-platelet or anti-coagulant agents (the patients who stop the medication for recommended wash-out period could be included) 14. Administration of other drugs for clinical trial within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of closure of macular hole estimated by optical coherence tomography | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of closure of macular hole estimated by optical coherence tomography;Changes of best corrected visual acuity (Snellen);Change of metamorphopsia estimated by M-chart;Change of amplitude and latency of electric potential in pattern visual evoked potential test;Change of score of The National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25) (Korean version) | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung-Hoon Park
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed