Surgery Clinical Trial
Official title:
Treating Rhegmatogenous Retinal Detachment by Foldable Capsular Buckle (FCB): a Randomized, Controlled, Single-blind and Multicenter Study
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.
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.
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