Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT00403702
Status:
WITHDRAWN
Last Update Posted:
2024-06-03
First Post:
2006-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison High-density Silicone Oils in Retinal Detachment
Sponsor:
Asociación para Evitar la Ceguera en México
Organization:
Study Overview
Official Title:
Comparison of Two High-Density Silicone Oils in Complicated Rhegmatogenous Retinal Detachment
Status:
WITHDRAWN
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: