Phase
Condition
Myopia
Treatment
Pars plana vitrectomy
Clinical Study ID
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients aged 20 years or older at the time of consent acquisition
Patients with binocular intensity myopia (myopia of -6.0 diopter (D) or more) orpatients with axial length (26 mm) or more equivalent to -6.0 D
Corrected characters of the test eye patients with visual acuity of less than 60characters (equivalent to decimal visual acuity 0.32)
Patients diagnosed with binocular myopic chorioretinal atrophy and having atrophy of 1 papillary diameter (1.5 mm) or more in the area within 2 papillary diameter (3.0mm) including the fovea centralis in the subject eye
Patients without active choroidal neovascularization
Exclusion
Exclusion Criteria:
Patients with abnormal findings that pose a problem in clinical trial participationin screening tests.
Patients with positive hepatitis B surface (HBs) antigen, Hepatitis C virus (HCV)antibody, Human immunodeficiency virus (HIV) antibody, Human T-lymphotropic virustype 1 (HTLV-1) antibody, syphilis serum reaction
Patients with allergies to human serum albumin antibiotics, trypsin
Patients with eye infections
Patients with other retinal diseases (diabetic retinopathy, hypertensiveretinopathy, vascular occlusion)
Patients with confirmed optic nerve atrophy
Patients with glaucoma who cannot control intraocular pressure
Patients with findings associated with myopic traction macular disease (apparentposterior macular tumor, vitreous macular traction, retinal separation, macular holedetachment, macular hole)
Patients with atrophy in all areas of the circle within 3 papilla diameter (4.5 mm) (9.0 mm in diameter) from the fovea
Patients with corrected visual acuity of control eye 0.08 or less
Patients with severe blood disorders, heart failure, liver disorders, and renaldisorders
Patients diagnosed with malignant tumor within 5 years or patients requiringtreatment
Pregnant women, lactating women, patients wishing to become pregnant during thetrial period
Patients who cannot discontinue anticoagulants or antiplatelet drugs before thetrial
Patients with drug addiction or alcoholism
Patients receiving treatment with vascular endothelial growth factor inhibitor orphotodynamic therapy within 4 months prior to transplantation for test eye or 2months for reference eye.
Patients who underwent eye surgery (excluding lens reconstruction) within 3 monthsbefore transplantation. In the case of cataract surgery, if 7 days or more havepassed since surgery and postoperative inflammation is stable, registration ispossible.
Study Design
Connect with a study center
Nagoya city university hospital
Nagoya, Aichi
JapanActive - Recruiting
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