Severe Proliferative Diabetic Retinopathy

This study has been completed.
Sponsor:
Information provided by:
Universita degli Studi di Catania
ClinicalTrials.gov Identifier:
NCT01115257
First received: May 3, 2010
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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).


Condition Intervention
Diabetic Retinopathy
Procedure: vitrectomy
Procedure: panretinalphotocoagulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Severe Proliferative Diabetic Retinopathy Treated With Vitrectomy or Panretinal Photocoagulation: a Prospective Comparative Study

Resource links provided by NLM:


Further study details as provided by Universita degli Studi di Catania:

Enrollment: 180
Study Start Date: October 2001
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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)

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01115257

Locations
Italy
1Department of Medicine and Surgery, Section of Ophthalmology, Santa Marta Hospital, University of Catania, Italy
Catania, Italy, 95100
Sponsors and Collaborators
Universita degli Studi di Catania
Investigators
Study Chair: Teresio Avitabile, Professor universita studi di Catania
  More Information

No publications provided by Universita degli Studi di Catania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Teresio Avitabile, 1Department of Medicine and Surgery, Section of Ophthalmology, Santa Marta Hospital, University of Catania, Italy
ClinicalTrials.gov Identifier: NCT01115257     History of Changes
Other Study ID Numbers: 0016258
Study First Received: May 3, 2010
Last Updated: May 3, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Universita degli Studi di Catania:
severe proliferative diabetic retinopathy
vitrectomy
panretinalphotocoagulation

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014