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Sponsored by: |
Asociación para Evitar la Ceguera en México |
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Information provided by: | Asociación para Evitar la Ceguera en México |
ClinicalTrials.gov Identifier: | NCT00403702 |
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.
Condition | Intervention | Phase |
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Retinal Detachment |
Drug: Oxane HD [oil-RMN3-mixture] Drug: Densiron [(F6H8) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Historical Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison High-Density Silicone Oils as an Intraocular Tamponade in Complex Retinal Detachment |
Estimated Enrollment: | 10 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jose Luis Diaz-Rubio, MD | +52 (55) 10841400 ext 1172 | retinamex@yahoo.com |
Mexico, D.F | |
Asociacion Para Evitar la Ceguera en Mexico | Recruiting |
Mexico, D.F, Mexico, 04330 | |
Contact: yoko burgoa +52 (55) 1084 1400 ext 1171 retinamex@yahoo.com | |
Contact: Mariana Martinez +52 (55) 1084 1400 ext 1171 retinamex@yahoo.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 | Asociacion para Evitar la Ceguera en MExico |
Study ID Numbers: | APEC-0021 |
Study First Received: | November 2, 2006 |
Last Updated: | November 24, 2006 |
ClinicalTrials.gov Identifier: | NCT00403702 |
Health Authority: | Mexico: Ethics Committee; Mexico: Ministry of Health |
Retinal detachment proliferative vitreoretinopathy heavier-than-water internal tamponades |
Retinal Detachment Eye Diseases Vitreoretinopathy, Proliferative Retinal Diseases |