A Study of a New Surgical Treatment of Macular Hole Retinal Detachment in High Myopia

Exclusion Criteria

• •1. Failure to comply with research or follow-up procedures;
• •2. Diabetes with uncontrolled blood glucose (defined as fasting plasma glucose more than 7.0mmol/L or blood glucose more than 11.1mmol/ L 2 hours postprandial), and / or with diabetic retinopathy;
• •3. Poor control of blood pressure in hypertensive patients (defined as blood pressure \>150/95mmHg, including antihypertensive medication);
• •4. With surgical contraindication due to other local or systemic conditions at screening or baseline;
• •5. With any active ocular or periocular infection or inflammation (e.g., blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at screening or baseline;
• •6. With uncontrolled glaucoma at screening or baseline (IOP ≥ 30mmHg when receiving medical treatment or as judged by the researchers);
• •7. With the presence of iris neovascularization or neovascular glaucoma at screening or baseline;
• •8. With ocular diseases which may interfere the study results at screening or baseline , including severe vitreous hemorrhage, peripheral retinal hole, proliferative diabetic retinopathy, proliferative vitreoretinopathy ( ≥ Level C ), choroidal detachment;
• •9. With other causes which may result in macular hole associated-retinal detachment at screening or baseline,except high myopia;
• •10. Previously underwent scleral buckling surgery;
• •11. With current or planned medication known to have toxic effects on the lens, retina or optic nerve, including hydroxychloroquine, chloroquine, hydroxychloroquine, tamoxifen, phenothiazine and ethambutol;
• •12. With laboratory abnormalities, such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TB), gamma-glutamyl transferase (GGT), lactate dehydrogenase (LDH), exceeded the normal limit by more than 2 times, and serum creatinine or blood urea nitrogen exceeded 1.2 times the normal limit;
• •13. With abnormal coagulation function (defined as more than normal prothrombin time for 3 seconds or more, more than 1.5 of the international standard ratio (INR), activated partial thromboplastin time of 10 seconds or longer than the upper limit of normal time); 14) Patients who participated in any clinical study of medication within 3 months prior to screening (excluding vitamins and minerals)
• •Exit criteria:
• •1. Due to adverse events, especially severe adverse events, the researchers consider withdrawal of patients based on concerns of safety and ethics;
• •2. Drop out;
• •3. The patients voluntarily withdraw the informed consent;
• •4. Serious violation of the study protocol due to the subjects or investigators' reasons;
• •5. Other reasons that the researchers believe for quitting the study