Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy
Condition: Diabetic Retinopathy; Retinal Detachment
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Retinal Detachment
Study type: Interventional

Summary: 
      Subjects receiving 16% C3F8 gas tamponade during vitrectomy will have better visual acuity
      and similar postoperative complications to subjects who receive silicone oil tamponade during
      vitrectomy.
    

Detailed description: 
      Severe vision loss in patients with proliferative diabetic retinopathy (PDR) frequently
      results from complications related to neovascularization and fibrovascular proliferation.
      Patients with PDR are typically considered candidates for pars plana vitrectomy (PPV) when
      non-clearing vitreous hemorrhaging, tractional retinal detachment (TRD) development with or
      without rhegmatogenous retinal detachment (RRD) or extensive fibrovascular proliferation
      occur. Visual prognosis is often guarded in patients with PDR undergoing PPV with higher
      grades of vitreoretinal (VR) adhesion because of the high rate of both intra-operative and
      postoperative complications. Releasing all significant traction caused by VR adhesion during
      PPV is critical for achieving long-term anatomic success and obtaining better visual outcomes
      in these patients with more advanced disease. Failure to relieve VR adhesion often leads to
      persistent, recurrent or de novo TRD with or without RRD in the perioperative and
      postoperative period, which then results in one or more reoperations and ultimately a poor
      visual prognosis. Maneuvers to remove VR adhesion during PPV are challenging and can result
      in posterior and/or peripheral retinal holes, which then may lead to postoperative
      proliferative vitreoretinopathy (PVR) and recurrent or de novo RRD. Silicone oil and
      long-acting gas tamponade have been employed during PPV with reported success in cases with
      complex RRD and PVR. And even though silicone oil and long-acting gas tamponade are currently
      in wide use for patients with PDR and high-grade VR adhesion undergoing PPV (especially when
      intra-operative breaks occur), little clinical data is available regarding which tamponading
      agent is best-suited for this patient population. Previous studies have been retrospective in
      nature and are tarnished by selection bias when tamponading agents are compared (i.e. cases
      with more severe grades of VR adhesion and intra-operative breaks typically are selected to
      receive silicone oil tamonade over gas). Presently, there are not any randomized controlled
      trials reported on this topic. In this randomized controlled trial, we compare silicone oil
      tamponade to 16% C3F8 gas tamponade in patients with PDR undergoing PPV for the management of
      TRD (with or without RRD) and/or extensive fibrovascular proliferation with or without
      vitreous hemorrhaging.
    

Intervention name(s): PPV/SO; PPV/C3F8
Intervention type(s): Procedure; Procedure
Intervention description(s): Subjects receive 1,000 centistoke silicone oil tamponade during vitrectomy; Subjects receive 16% C3F8 gas tamponade during vitrectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment