Severe Proliferative Diabetic Retinopathy

NCT ID: NCT01115257

Last Updated: 2010-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31

Brief 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)

Conditions

Diabetic Retinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: OTHER

vitrectomy

Intervention Type: PROCEDURE

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.

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

Group Type: OTHER

panretinalphotocoagulation

Intervention Type: PROCEDURE

Panretinal photocoagulation was completed according to guidelines summarized in ETDRS with extensive full subconfluent panretinal photocoagulation.

Interventions

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.

Intervention Type: PROCEDURE

panretinalphotocoagulation

Panretinal photocoagulation was completed according to guidelines summarized in ETDRS with extensive full subconfluent panretinal photocoagulation.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita degli Studi di Catania

OTHER

Sponsor Role: lead

Responsible Party

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

Principal Investigators

Teresio Avitabile, Professor

Role: STUDY_CHAIR

universita studi di Catania

Locations

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

Catania, Italy, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 21816255 (View on PubMed)

Other Identifiers

0016258

Identifier Type: -

Identifier Source: org_study_id