Efficacy of autologous platelet concentrate on macular hole surgery
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0002686
- Lead Sponsor
- ational Evidence-based Healthcare Callaborating Agency
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 194
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of closure of macular hole estimated by optical coherence tomography
- Secondary Outcome Measures
Name Time Method 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)