Prospective, multicenter, randomized, single-blind, parallel-controlled clinical trial to evaluate the safety and efficacy of perfluoropropane for ophthalmic surgery

Rhegmatogenous retinal detachment (RRD) is a common sight-threatening ophthalmic emergency requiring surgical intervention. This study aims to evaluate the safety and efficacy of experimental perfluoropropane (C3F8) for intraocular tamponade during vitreoretinal surgery. A prospective randomized controlled trial was designed to assess the efficacy and safety of the experimental C3F8. A total of 136 patients with RRD requiring C3F8-assisted treatment from six centers in China were randomized in a 1:1 ratio into the control group or the experimental group. The control group used C3F8 from AL.CHI.MI.A.Srl (Italy), whereas the experimental group utilized C3F8 from Shanghai Jessi Medical Technology Co., Ltd (China). Follow-up assessments were conducted at 1, 7, 14, 28, and 60 d postoperatively. The primary outcome was retinal reattachment rate at 7 d post-surgery. The secondary outcomes included retinal reattachment rates at 1, 14, 28, and 60 d post-surgery, changes in best corrected visual acuity (BCVA), intraocular pressure (IOP), and gas retention. Safety assessments included systemic and ocular adverse events. Differential analysis of these indicators between the two groups were performed to evaluate the efficacy and safety of the experimental C3F8. At 7 d post-surgery, the complete retinal reattachment rate was 100% in the control group and 98.41% in the experimental group (P > 0.05). No significant differences were observed between the two groups across all follow-up time points in secondary outcomes and safety indicators. In patients undergoing pars plana vitrectomy (PPV) for retinal detachment, experimental C3F8 demonstrates non-inferior to control C3F8 as an intraocular tamponade. Both variants are safe and well-tolerated.