Comparison High-density Silicone Oils in Retinal Detachment

Status Withdrawn

Clinical Trial Summary

The purpose of the study is to compare the safety, intraocular adverse effects and the anatomic and functional outcome with two endotamponade silicone oil after a 3-month in complex inferior retinal re-detachments.

Clinical Trial Description

Five to 10% of retinal detachments progressed to proliferative vitreoretinopathy (PVR), the common more cause of surgical failure of retina detachment. Despite the use of internal tamponades, the treatment of retinal detachments due to a progressed proliferative vitreoretinopathy (PVR) is still a problem. At present, conventional silicone oil, having a lower specific gravity than water, is an excellent tool in advanced PVR retinal detachment especially of the upper circumference. In the past, to diminish the re-detachments diverse heavier-than-water density endotamponades were investigated by to use in in cases of inferior PVR. However,heavier-than-water density endotamponades have demonstrated adverse short term effects. (Example: silicon dispersion: hypotension and inflammation) Recently, two new long-term heavier-than-water internal tamponades were introduced: Oxane HD [oil-RMN3-mixture] and Densiron [mixture of 30.5 vol% perfluorohexyloctane (F6H8) with 69.5 vol% polydimethylsiloxane (silicone oil)], showing satisfying anatomical results and good intraocular tolerance. In the present study, we will compare the anatomical outcome, functional results and intraocular adverse effects of two types of heavier tamponades. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00403702
Study type	Interventional
Source	Asociación para Evitar la Ceguera en México
Contact
Status	Withdrawn
Phase	Phase 2/Phase 3
Start date	August 2006
Completion date	August 2007

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