A Single Center, Randomized and Controlled Clinical Study of Inverted Internal Limiting Membrane Insertion Combined With Air Tamponade in the Treatment of Macular Hole Retinal Detachment in High Myopia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Macular hole closure rate
研究概览
简要总结
This study evaluates the surgical outcomes of inverted internal limiting membrane insertion combined with air tamponade in the treatment of macular hole retinal detachment (MHRD) in high myopia, and also to compare the treatment efficacy and safety between different surgical approaches of MHRD
详细描述
This study uses a new surgical method (vitrectomy combined with inverted internal limiting membrane insertion and intraocular sterilized air tamponade) to assess its effectiveness and safety on the prognosis of macular hole retinal detachment secondary to high myopia, and also compares this new type of surgery with the current commonly used surgery (vitrectomy combined with internal limiting membrane peeling + silicone oil infusion).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
In this study, the third party independent evaluation method is used to evaluate the results of the study. The analyzer is in the masking state, and the subjects and the surgeons are in the non-masking state..
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior written informed consent should be obtained before any assessment is carried out;
- •Participants are more than 18 years of age, and less than 75 years of age, male or female Chinese patients;
- •Visual impairment is caused by macular hole associated with retinal detachment secondary to high myopia;
- •Axial length ≥ 26mm, or the refractive error ≥ -6.0D
排除标准
- •Failure to comply with research or follow-up procedures;
- •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;
- •Poor control of blood pressure in hypertensive patients (defined as blood pressure >150/95mmHg, including antihypertensive medication);
- •With surgical contraindication due to other local or systemic conditions at screening or baseline;
- •With any active ocular or periocular infection or inflammation (e.g., blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at screening or baseline;
- •With uncontrolled glaucoma at screening or baseline (IOP ≥ 30mmHg when receiving medical treatment or as judged by the researchers);
- •With the presence of iris neovascularization or neovascular glaucoma at screening or baseline;
- •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;
- •With other causes which may result in macular hole associated-retinal detachment at screening or baseline,except high myopia;
- •Previously underwent scleral buckling surgery;
- •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;
- •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;
- •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:
- •Due to adverse events, especially severe adverse events, the researchers consider withdrawal of patients based on concerns of safety and ethics;
- •The patients voluntarily withdraw the informed consent;
- •Serious violation of the study protocol due to the subjects or investigators' reasons;
- •Other reasons that the researchers believe for quitting the study
研究组 & 干预措施
Group 1
Group 1: The patients in Group 1 are treated by the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + air-fluid exchange + silicone oil infusion
干预措施: Group 1 (Procedure)
Group 2
Group 2: The patients in Group 2 are treated by the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + inverted internal limiting membrane insertion + air-fluid exchange
干预措施: Group 2 (Procedure)
结局指标
主要结局
Macular hole closure rate
时间窗: 3 months after operation
Fundus examination combined with optical coherence tomography (OCT) are performed 3 months after surgery.
次要结局
- Postoperative complication rate of ocular adverse events(Within 12 months after operation)
- Best corrected visual acuity(12 months after the operation)
- Postoperative complication rate of severe adverse events(Within 12 months after operation)
- Reattachment rate of retinal detachment(12 months after the operation)
- Postoperative complication rate of the non ocular adverse events(Within 12 months after operation)
- Best corrected visual acuity(6 months after the operation)
- Reattachment rate of retinal detachment(6 months after the operation)
研究者
Fenghua Wang
Doctoral supervisor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine