Silicone Oil Versus Long-acting Gas Tamponade in Proliferative Diabetic Retinopathy Patients With High-grade Vitreoretinal Adhesion Undergoing Vitrectomy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetic Retinopathy
- Retinal Detachment
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
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 hemorrhag...
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.
Tracking Information
- NCT #
- NCT03660384
- Collaborators
- Not Provided
- Investigators
- Not Provided