Treating Rhegmatogenous Retinal Detachment by Foldable Capsular Buckle (FCB): a Randomized, Controlled, Single-blind and Multicenter Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- fundus photography
研究概览
简要总结
To evaluate the efficacy and safety of treating rhegmatogenous retinal detachment (RRD) using foldable capsular buckle (FCB). It is a multi-center clinical ,randomized, controlled, and single-blind clinical study.
详细描述
The purpose of this study is to compare the safety, effectiveness, and operability of FCB scleral buckling and silicone scleral buckling in the treatment of RRD. It is a multi-center clinical study and is designed according to a randomized, controlled, and single-blind clinical research protocol. Before surgery, the retinal tear in the FCB group and the control group of RRD patients should be examined and precise positioned by fundus photography, and the relevant results will be determined by the third-party reading center to confirm that the patients can accept such surgery.
The key instrument required by the FCB group is FCB. During FCB implantation, 1 ml of basic Ringer's solution will be injected as FCB, and then the balloon filled, so that the outer surface of the balloon is in close contact with the sclera, and the top The function of scleral compression helps to close the hiatus. The key surgical instrument used in the control group is silicone, but it does not require ring surgery. Silicone is also fixed to the outer surface of the sclera. After the conjunctiva and Tenon 's sac separated, the primary endpoint will be evaluated three months after surgery, and both groups will be followed up to one year after surgery. Relevant data will be collected and kept by full-time personnel, and then the statistical analysis of the data will be used to evaluate the safety, effectiveness, and operability of FCB implantation, and compare the treatment effect with the control group.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age, regardless of gender.
- •The axial length of the operative eye ≤26 mm (myopia <600 degrees).
- •Meet diagnostic criteria for RRD (a single lacuna of <2 PD in one quadrant or multiple adjacent lacunae of <3 PD, up to PVR-B grade).
- •Be able to understand the purpose of the study, participate voluntarily and sign an informed consent form.
排除标准
- •Patients with known allergies to silicone, scarred bodies.
- •Intraocular inflammation.
- •PVR-C and above.
- •Cracked hole with crimped edges, with pulling.
- •Obvious vitreous pulling and retinal fixation folds.
- •the lacunae are large or scattered and the scleral ridge formed by the estimated FCB does not fully encompass the lacunae.
- •Other associated ophthalmic diseases beyond control, such as glaucoma, tertiary nuclear cataracts and macular diseases.
- •Severe hepatic and renal impairment and/or severe systemic diseases (e.g. cardiovascular, respiratory, digestive, neurological, endocrine, genitourinary, etc.).
- •Females who are already pregnant (determined by urine pregnancy study at the first visit), who are preparing for pregnancy during the study and who are lactating.
- •History of substance abuse or alcoholism.
- •Have participated in another clinical study of a drug or medical device within 30 days prior to the screening of this clinical study.
- •Any condition of the patient that the research doctor believes would hinder clinical research (e.g. the patient is prone to stress, uncontrolled emotions, depression, etc.).
- •Those who do not agree to be selected or do not agree to be followed up.
结局指标
主要结局
fundus photography
时间窗: 12 weeks after surgery
The retinal repositioning will be observed and the images will be reviewed by a third-party film review committee for final results.
Optical Coherence Tomography, OCT
时间窗: 24 weeks after surgery
Check to see if the retina is reset.The macula is defined as a central depression within a diameter of 5.5 mm.
次要结局
未报告次要终点