Severe Proliferative Diabetic Retinopathy
Primary Purpose
Diabetic Retinopathy
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
vitrectomy
panretinalphotocoagulation
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring severe proliferative diabetic retinopathy, vitrectomy, panretinalphotocoagulation
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.
Sites / Locations
- 1Department of Medicine and Surgery, Section of Ophthalmology, Santa Marta Hospital, University of Catania, Italy
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
group 1
panretinalphotocoagulation (group 2)
Arm Description
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
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
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01115257
First Posted
May 3, 2010
Last Updated
May 3, 2010
Sponsor
Universita degli Studi di Catania
1. Study Identification
Unique Protocol Identification Number
NCT01115257
Brief Title
Severe Proliferative Diabetic Retinopathy
Official Title
Severe Proliferative Diabetic Retinopathy Treated With Vitrectomy or Panretinal Photocoagulation: a Prospective Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Universita degli Studi di Catania
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
severe proliferative diabetic retinopathy, vitrectomy, panretinalphotocoagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Other
Arm Description
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
Arm Title
panretinalphotocoagulation (group 2)
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
vitrectomy
Intervention Description
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
Intervention Name(s)
panretinalphotocoagulation
Intervention Description
Panretinal photocoagulation was completed according to guidelines summarized in ETDRS with extensive full subconfluent panretinal photocoagulation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresio Avitabile, Professor
Organizational Affiliation
universita studi di Catania
Official's Role
Study Chair
Facility Information:
Facility Name
1Department of Medicine and Surgery, Section of Ophthalmology, Santa Marta Hospital, University of Catania, Italy
City
Catania
ZIP/Postal Code
95100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
21816255
Citation
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.
Results Reference
derived
Learn more about this trial
Severe Proliferative Diabetic Retinopathy
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