Severe Proliferative Diabetic Retinopathy

Severe Proliferative Diabetic Retinopathy Treated With Vitrectomy or Panretinal Photocoagulation: a Prospective Comparative Study

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).

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Procedure: vitrectomy; Procedure: panretinalphotocoagulation

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)

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Catania, Italy, 95100
    • 1Department of Medicine and Surgery, Section of Ophthalmology, Santa Marta Hospital, University of Catania, Italy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Eyes with advanced Proliferative diabetic retinopathy some with TRD not involving the macula. The definition of severe PDR included eyes with extensive, active neovascular and fibrovascular proliferation graded using Modified Airlie House Classification

Exclusion Criteria:

• Eyes with fibrovascular tractional detachment involving the macula were excluded. Eyes with a combined tractional and rhegmatogenous retinal detachment and eyes with a history of uveitis or trauma, with previous vitrectomy and neovascular glaucoma were also excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: group 1; 90 eyes of 90 patients, with severe PDR, some with tractional retinal detachment (TRD) not involving the macula were included in the study and treated with vitrectomy	Procedure: vitrectomy; 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.
Other: panretinalphotocoagulation (group 2); 90 eyes of 90 patients, with severe PDR, some with tractional retinal detachment (TRD) not involving the macula were included in the study and treated with panretinalphotocoagulation	Procedure: panretinalphotocoagulation; Panretinal photocoagulation was completed according to guidelines summarized in ETDRS with extensive full subconfluent panretinal photocoagulation.

Collaborators and Investigators

• Sponsor: Universita degli Studi di Catania
• Investigators: Study Chair: Teresio Avitabile, Professor, universita studi di Catania

Publications and helpful links

General Publications

• Avitabile T, Bonfiglio V, Castiglione F, Castaing M, Contarino F, Mistretta A. Severe proliferative diabetic retinopathy treated with vitrectomy or panretinal photocoagulation: a monocenter randomized controlled clinical trial. Can J Ophthalmol. 2011 Aug;46(4):345-51. doi: 10.1016/j.jcjo.2011.06.012. Epub 2011 Jul 7.

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: May 3, 2010
• First Submitted That Met QC Criteria: May 3, 2010
• First Posted (Estimate): May 4, 2010

Study Record Updates

• Last Update Posted (Estimate): May 4, 2010
• Last Update Submitted That Met QC Criteria: May 3, 2010
• Last Verified: October 1, 2006

More Information

Terms related to this study

• Keywords: vitrectomy; severe proliferative diabetic retinopathy; panretinalphotocoagulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: 0016258