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Severe Proliferative Diabetic Retinopathy

NCT01115257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2010-05-04

No results posted yet for this study

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).

Conditions

Interventions

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.

PROCEDURE

panretinalphotocoagulation

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

Sponsors & Collaborators

  • Universita degli Studi di Catania

    lead OTHER

Principal Investigators

  • Teresio Avitabile, Professor · universita studi di Catania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2006-10-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01115257 on ClinicalTrials.gov