A Phase 2/3 interventional study of Oxane HD [oil-RMN3-mixture] and Densiron [(F6H8) in Retinal Detachment, sponsored by Asociación para Evitar la Ceguera en México. Withdrawn at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-03.
Sponsored by Asociación para Evitar la Ceguera en México · Phase 2/3, Interventional, and Treatment
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.
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.
199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.
Browse Retinal Detachment studies →Asociación para Evitar la Ceguera en México is the lead sponsor of 60 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
visual acuity
anatomical results
complication: hypotony,
vitreous hemorrhage,
inflammatory reaction,
cataract,
chronic hypotony,
IOP elevated intraocular pressure,
pseudohypopyon,
fibrin,
emulsification droplets in the anterior chamber
Ran from Aug 2006 to primary completion in Aug 2006, 0 months.
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This study is withdrawn, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Asociación para Evitar la Ceguera en México