Comparison High-Density Silicone Oils in Retinal Detachment
|ClinicalTrials.gov Identifier: NCT00403702|
Recruitment Status : Unknown
Verified November 2006 by Asociación para Evitar la Ceguera en México.
Recruitment status was: Recruiting
First Posted : November 27, 2006
Last Update Posted : June 30, 2009
|Condition or disease||Intervention/treatment||Phase|
|Retinal Detachment||Drug: Oxane HD [oil-RMN3-mixture] Drug: Densiron [(F6H8)||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison of Two High-Density Silicone Oils in Complicated Rhegmatogenous Retinal Detachment|
|Study Start Date :||August 2006|
|Estimated Study Completion Date :||August 2007|
- visual acuity
- anatomical results
- complication: hypotony,
- vitreous hemorrhage,
- inflammatory reaction,
- chronic hypotony,
- IOP elevated intraocular pressure,
- emulsification droplets in the anterior chamber
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00403702
|Contact: Jose Luis Diaz-Rubio, MD||+52 (55) 10841400 ext email@example.com|
|Asociacion Para Evitar la Ceguera en Mexico||Recruiting|
|Mexico, D.F, Mexico, 04330|
|Contact: yoko burgoa +52 (55) 1084 1400 ext 1171 firstname.lastname@example.org|
|Contact: Mariana Martinez +52 (55) 1084 1400 ext 1171 email@example.com|
|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|