myopic tractional maculopathy
Conditions
Interventions
macular buckling surgery group:macular buckling surgery
Sponsors
Tongji Hospital, Tongji Medical College of HUST
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Participants aged between 18 and 70 years old, of any gender. (2) High myopia (equivalent spherical refractive error = -6D or axial length = 26.5mm) with a confirmed posterior staphyloma. (3) Baseline Best-Corrected Visual Acuity (BCVA) in the study eye ranging from 4 letters to 73 letters (including the threshold values), approximately equivalent to Snellen visual acuity of 0.02 to 0.5, with a BCVA in the fellow eye = 0.05. (4) OCT examination revealing macular retinal detachment involving the central fovea. (5) Participants with sufficient compliance for study follow-up. (6) If both eyes meet the trial criteria, the eye with the longer axial length is typically selected for inclusion. If the axial lengths are equal, the inclusion eye is determined after an assessment of risk and benefit by the investigator and the participant.
Exclusion criteria
Exclusion criteria: 1)Target eyes with full-thickness macular holes. 2)Target eyes with severe cataracts or those expected to require cataract surgery during the follow-up period. 3)Corneal opacities or keratoconus that prevent the observation of the fundus, or inability to obtain fundus imaging data. 4)Target eyes with macular hemorrhage, active choroidal neovascularization, or extensive scarring beneath the central fovea. 5)Target eyes with peripheral retinal detachment with foramen or retinal detachment combined with choroidal detachment. 6)Target eyes where macular retinal detachment extends beyond the central area and involves more than one quadrant. 7)Target eyes with concomitant active inflammation, such as conjunctivitis, keratitis, uveitis, optic neuritis, orbital inflammation, or scleritis. 8)Target eyes with uncontrolled glaucoma (defined as intraocular pressure persistently =25mmHg after the use of ocular hypotensive medications, or those expected to require glaucoma surgery during the study. 9)Target eyes that have undergone corneal transplant surgery, ocular repair, cataract surgery, orbital tumor excision, vitrectomy, scleral buckle or posterior scleral reinforcement, ICL implantation, or similar surgeries. 10)Clear history of significant ocular trauma. 11)Target eyes with confirmed optic nerve atrophy, retinal vascular occlusion, retinal bleeding, or diabetic retinopathy. 12)Pregnant, lactating, or women with recent plans for pregnancy. 13)Allergies to silicone, titanium, or components used in the research process (such as disinfectants or anesthetics. 14)Uncontrolled hypertension, defined as systolic blood pressure =160mmHg or diastolic blood pressure =95mmHg while seated after receiving antihypertensive treatment. 15)Any uncontrollable clinical issues (such as severe mental, neurological, cardiovascular, respiratory, hematological disorders, or malignancies). 16)Uncontrolled diabetes, fasting blood sugar =10.0µmol/L. 17)A history of kidney transplantation or patients with renal failure requiring hemodialysis or peritoneal dialysis. 18)History of stroke, myocardial infarction, transient ischemic attacks, or other thrombotic events within the last 6 months before enrollment. 19)Currently undergoing treatment for systemic infections. 20)Participation in other clinical trials within the month preceding enrollment. 21)Other conditions deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCVA;axis length;Anatomical reduction rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| intraocular pressure; | — |
Countries
China
Contacts
Public ContactSun Xufang
Tongji Hospital, Tongji Medical College of HUST
Outcome results
None listed