Severe Proliferative Diabetic Retinopathy
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional

Summary: 
      The purpose of this study is to examine and compare, prospectively, best corrected visual
      acuity (BCVA) outcomes and complications of a cohort of patients with Proliferative Diabetic
      Retinopathy and Tractional Retinal Detachment not involving macula undergoing pars plana
      vitrectomy (PPV) or conventional management (panretinal photocoagulation).
    

Detailed description: 
      The utility and practice of Panretinalphotocoagualtion (PRP) in patients with high-risk
      Proliferative Diabetic Retinopathy (PDR) have not changed since the ETDRS reported guidelines
      in 1987. A meta-analysis of the DRS and ETDRS two large U.S. RCT of laser therapy for PDR
      confirmed the effectiveness of PRP (Level I evidence). Both trials had large sample sizes,
      excellent compliance and adequate follow-up. These studies established that PRP reduces the
      risk of severe visual loss in patients with high-risk PDR by 50% to 60%20.

      With the arrival of the vitrectomy, this surgery was often used to treat eyes with severe
      complications from PDR. The most common indications for vitrectomy were nonclearing vitreous
      hemorrhage, Tractional Retinal Detachment(TRD) with macular involvement, and combined
      traction and rhegmatogenous retinal detachment. With the addition of new indications to the
      known indications vitrectomy has been performed in earlier stages(severe PDR). A large number
      of case series reports have assessed the effect of pars plana vitrectomy on diabetic TRD with
      or without macular detachment but the level of evidence was low and they included patients
      not homogeneous. These studies have generally shown benefit, with improved vision seen in
      many patients (ranging from 22% to 65%) but they have also indicated a high rate of operative
      and postoperative complications. These numerous intra and post-operative complications could
      lead to satisfying anatomical results but poor vision.The purpose of this study is to examine
      and compare, prospectively, best corrected visual acuity (BCVA) outcomes and complications of
      a cohort of patients with Proliferative Diabetic Retinopathy and Tractional Retinal
      Detachment not involving macula undergoing pars plana vitrectomy (PPV) or conventional
      management (panretinal photocoagulation)
    

Intervention name(s): vitrectomy; panretinalphotocoagulation
Intervention type(s): Procedure; Procedure
Intervention description(s): The surgical technique (Group 1) included vitrectomy, with a combination of delamination and segmentation of gliotic tractional membranes using bimanual technique. Silicone oil tamponade was used in eyes with long-standing tractional retinal detachment, as deemed necessary by the surgeon, or in eyes in which a retinal break occurred during the vitrectomy.; Panretinal photocoagulation was completed according to guidelines summarized in ETDRS with extensive full subconfluent panretinal photocoagulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: severe proliferative diabetic retinopathy; vitrectomy; panretinalphotocoagulation