Comparison High-Density Silicone Oils in Retinal Detachment
Recruitment status was Recruiting
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.
Drug: Oxane HD [oil-RMN3-mixture]
Drug: Densiron [(F6H8)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Comparison of Two High-Density Silicone Oils in Complicated Rhegmatogenous Retinal Detachment|
- visual acuity
- anatomical results
- complication: hypotony,
- vitreous hemorrhage,
- inflammatory reaction,
- chronic hypotony,
- IOP elevated intraocular pressure,
- emulsification droplets in the anterior chamber
|Study Start Date:||August 2006|
|Estimated Study Completion Date:||August 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403702
|Contact: Jose Luis Diaz-Rubio, MD||+52 (55) 10841400 ext firstname.lastname@example.org|
|Asociacion Para Evitar la Ceguera en Mexico||Recruiting|
|Mexico, D.F, Mexico, 04330|
|Contact: yoko burgoa +52 (55) 1084 1400 ext 1171 email@example.com|
|Contact: Mariana Martinez +52 (55) 1084 1400 ext 1171 firstname.lastname@example.org|
|Principal Investigator: Jose Luis Diaz-Rubio, MD|
|Sub-Investigator: Maximiliano Gordon|
|Sub-Investigator: Veronica Kon-Jara|
|Sub-Investigator: Mitzy Torres|
|Sub-Investigator: Orlando Ustariz|
|Sub-Investigator: Gerardo Garcia-Aguirre|
|Study Director:||Hugo Quiroz-Mercado, MD||Asociación para Evitar la Ceguera en México|