The Exploratory Clinical Trials on the Primary Safety and Effectiveness of High Myopic Posterior Scleral Fixation System

This is an interventional treatment trial for High Myopia focused on measuring Posterior scleral reinforcement, Macular ischemia Read More

Inclusion Criteria:

1. Age 18~65, male or female;
2. Refractive ranges from -6.00d to -25.00d;
3. The axial length of the operative eye was 26-32mm;
4. Macular cleavage 200-1000μm;
5. Corrected visual acuity of the operative eye < 0.3;
6. Able to understand the purpose of the test, voluntarily participate and sign the informed consent form.

Exclusion Criteria:

1. Known allergy to silica gel and patients with scar constitution;
2. Ocular inflammation;
3. Fundus hemorrhage;
4. Macular hole;
5. Macular cleavage of the contralateral eye greater than 200μm;
6. Corrected visual acuity of contralateral eye < 0.4;
7. Opacity of the refractive medium;
8. Eye tumor;
9. History of hyperthyroidism;
10. Other ophthalmic concomitant diseases that cannot be controlled, such as diabetic retinopathy, hypertensive fundus lesions, optic nerve atrophy, etc.;
11. Severe impairment of liver and kidney function and/or severe systemic diseases (such as cardiovascular, respiratory, digestive, nervous, endocrine, genitourinary, etc., depending on the tolerance of surgery);
12. Women who are pregnant (determined by a blood pregnancy test at the first visit), who are preparing for pregnancy during the test, and who are breastfeeding;
13. a history of drug abuse or alcohol abuse;
14. participate in other drug or medical device clinical trials within 30 days prior to the screening of this clinical trial;
15. Any condition of the subject that the study physician considers to be an impediment to the clinical trial (e.g. subject's susceptibility to mental stress, uncontrollable mood, depression, etc.);
16. Poor compliance of the subject, unable to complete the test process as required.