Comparison High-Density Silicone Oils in Retinal Detachment
Primary Purpose
Retinal Detachment
Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Oxane HD [oil-RMN3-mixture]
Densiron [(F6H8)
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Detachment focused on measuring Retinal detachment, proliferative vitreoretinopathy, heavier-than-water internal tamponades
Eligibility Criteria
Inclusion Criteria:
- Patients complicated persistent retinal detachment due secondary to proliferative vitreoretinopathy
Exclusion Criteria:
- Diabetes
- Uveitis
- Glaucoma
Sites / Locations
- Asociacion Para Evitar la Ceguera en MexicoRecruiting
Outcomes
Primary Outcome Measures
visual acuity
anatomical results
Secondary Outcome Measures
complication: hypotony,
vitreous hemorrhage,
inflammatory reaction,
cataract,
chronic hypotony,
IOP elevated intraocular pressure,
pseudohypopyon,
fibrin,
emulsification droplets in the anterior chamber
Full Information
NCT ID
NCT00403702
First Posted
November 2, 2006
Last Updated
June 28, 2009
Sponsor
Asociación para Evitar la Ceguera en México
1. Study Identification
Unique Protocol Identification Number
NCT00403702
Brief Title
Comparison High-Density Silicone Oils in Retinal Detachment
Official Title
Comparison of Two High-Density Silicone Oils in Complicated Rhegmatogenous Retinal Detachment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Asociación para Evitar la Ceguera en México
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
Retinal detachment, proliferative vitreoretinopathy, heavier-than-water internal tamponades
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oxane HD [oil-RMN3-mixture]
Intervention Type
Drug
Intervention Name(s)
Densiron [(F6H8)
Primary Outcome Measure Information:
Title
visual acuity
Title
anatomical results
Secondary Outcome Measure Information:
Title
complication: hypotony,
Title
vitreous hemorrhage,
Title
inflammatory reaction,
Title
cataract,
Title
chronic hypotony,
Title
IOP elevated intraocular pressure,
Title
pseudohypopyon,
Title
fibrin,
Title
emulsification droplets in the anterior chamber
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients complicated persistent retinal detachment due secondary to proliferative vitreoretinopathy
Exclusion Criteria:
Diabetes
Uveitis
Glaucoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Luis Diaz-Rubio, MD
Phone
+52 (55) 10841400
Ext
1172
Email
retinamex@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo Quiroz-Mercado, MD
Organizational Affiliation
Asociación para Evitar la Ceguera en México
Official's Role
Study Director
Facility Information:
Facility Name
Asociacion Para Evitar la Ceguera en Mexico
City
Mexico
State/Province
D.F
ZIP/Postal Code
04330
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yoko burgoa
Phone
+52 (55) 1084 1400
Ext
1171
Email
retinamex@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mariana Martinez
Phone
+52 (55) 1084 1400
Ext
1171
Email
retinamex@yahoo.com
First Name & Middle Initial & Last Name & Degree
Jose Luis Diaz-Rubio, MD
First Name & Middle Initial & Last Name & Degree
Maximiliano Gordon
First Name & Middle Initial & Last Name & Degree
Veronica Kon-Jara
First Name & Middle Initial & Last Name & Degree
Mitzy Torres
First Name & Middle Initial & Last Name & Degree
Orlando Ustariz
First Name & Middle Initial & Last Name & Degree
Gerardo Garcia-Aguirre
12. IPD Sharing Statement
Citations:
PubMed Identifier
16205937
Citation
Sandner D, Engelmann K. First experiences with high-density silicone oil (Densiron) as an intraocular tamponade in complex retinal detachment. Graefes Arch Clin Exp Ophthalmol. 2006 May;244(5):609-19. doi: 10.1007/s00417-005-0110-8. Epub 2005 Oct 5.
Results Reference
background
PubMed Identifier
15029505
Citation
Theelen T, Tilanus MA, Klevering BJ. Intraocular inflammation following endotamponade with high-density silicone oil. Graefes Arch Clin Exp Ophthalmol. 2004 Jul;242(7):617-20. doi: 10.1007/s00417-004-0898-7. Epub 2004 Mar 17.
Results Reference
background
PubMed Identifier
1483133
Citation
Nicolai U, Eckardt C, Kohlhoff M, Wottge HU. Biocompatibility of silicone oil and high-density liquids. An immunologic study. Ger J Ophthalmol. 1992;1(3-4):180-7.
Results Reference
background
PubMed Identifier
3737116
Citation
Mester U, Rothe R, Zubcov A. Experimental studies with a high-density silicone oil for giant retinal tear. Ophthalmic Res. 1986;18(2):81-6. doi: 10.1159/000265419.
Results Reference
background
PubMed Identifier
16625267
Citation
Wong D, Cazabon S, Ali H, Kumar I, Valldeperas X, Groenewald C, Pearce I. Can the sequential use of conventional silicone oil and heavy oil be a strategy for the management of proliferative vitreoretinopathy? Ann Acad Med Singap. 2006 Mar;35(3):181-4.
Results Reference
background
PubMed Identifier
16523153
Citation
Scheer S, Boni S, Barale PO, Bourhis A, Bonnel S, Tuil E, Girmens JF, Buil O, Baudouin C, Laroche L, Nordmann JP, Poisson F, Warnet JM, Sahel JA. [Heavy silicone oil as internal tamponade for retinal detachment: efficacy and tolerance]. J Fr Ophtalmol. 2006 Feb;29(2):129-35. doi: 10.1016/s0181-5512(06)73760-3. French.
Results Reference
background
PubMed Identifier
16139666
Citation
Tognetto D, Minutola D, Sanguinetti G, Ravalico G. Anatomical and functional outcomes after heavy silicone oil tamponade in vitreoretinal surgery for complicated retinal detachment: a pilot study. Ophthalmology. 2005 Sep;112(9):1574. doi: 10.1016/j.ophtha.2005.04.013.
Results Reference
background
PubMed Identifier
15923493
Citation
Bhisitkul RB, Gonzalez VH. "Heavy oil" for intraocular tamponade in retinal detachment surgery. Br J Ophthalmol. 2005 Jun;89(6):649-50. doi: 10.1136/bjo.2004.057182. No abstract available.
Results Reference
background
PubMed Identifier
12824833
Citation
Wolf S, Schon V, Meier P, Wiedemann P. Silicone oil-RMN3 mixture ("heavy silicone oil") as internal tamponade for complicated retinal detachment. Retina. 2003 Jun;23(3):335-42. doi: 10.1097/00006982-200306000-00008.
Results Reference
background
PubMed Identifier
15983817
Citation
Rizzo S, Genovesi-Ebert F, Belting C, Vento A, Cresti F. A pilot study on the use of silicone oil-RMN3 as heavier-than-water endotamponade agent. Graefes Arch Clin Exp Ophthalmol. 2005 Nov;243(11):1153-7. doi: 10.1007/s00417-005-0015-6. Epub 2005 Jun 28.
Results Reference
background
PubMed Identifier
32408387
Citation
Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.
Results Reference
derived
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Comparison High-Density Silicone Oils in Retinal Detachment
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