Progressive pathological myopia
Conditions
Interventions
ADM-PSR Group:Posterior scleral reinforcement with application of acellular allogeneic dermal matrix (ADM).
Homologous Dura Mater PSR Group:Posterior scleral reinforcement with allogeneic dura mater graft
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years, regardless of gender; 2. Diagnosed with pathological myopia, and according to traceable past medical records (with an interval of at least 6 months), the study eye shows an average annual increase in axial length >= 0.2 mm or an average annual progression of spherical equivalent <= -0.50 D. 3. The study eye is not accompanied by significant myopic traction maculopathy requiring urgent surgical intervention (such as severe macular schisis, macular hole with retinal detachment, etc.). 4. Able to understand the purpose of the trial and voluntarily participate, with informed consent signed by the patient themselves or their family members.
Exclusion criteria
Exclusion criteria: 1. Severe vitreomacular traction syndrome or myopic traction maculopathy caused by severe epiretinal membrane present preoperatively; 2. Other ocular diseases present preoperatively, such as glaucoma, choroidal neovascularization, acute conjunctivitis, or other progressive or acute eye conditions; 3. History of penetrating ocular trauma or other serious ocular injury in the study eye that may affect the study outcomes; 4. History of previous ocular surgery in the study eye that may affect the study outcomes, such as scleral buckling surgery or posterior scleral reinforcement surgery; 5. Patients with severe refractive media opacity affecting fundus examination or OCT scanning; 6. Patients unable to tolerate surgery; 7. Patients currently using or requiring long-term use of ocular or systemic medications during the study period that may affect vision, such as corticosteroids, immunosuppressants, anti-tuberculosis drugs, etc.; 8. Patients who have participated in other drug or medical device clinical trials within 30 days prior to screening; 9. Pregnant or breastfeeding women; 10. Patients with severe cardiovascular or cerebrovascular diseases unable to cooperate with examinations; 11. Patients unable to undergo regular follow-up visits for other reasons; 12. Best-corrected visual acuity in the non-study eye < 0.05; 13. Other circumstances where the investigator deems the patient unsuitable for enrollment; 14 Patients judged by the investigator to be unable to complete at least 12 months of regular follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial Length Control Success Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Best-Corrected Visual Acuity (BCVA); | — |
Countries
China
Contacts
Public ContactXu Xu
Eye Hospital, Wenzhou Medical University
Outcome results
None listed