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Comparison High-Density Silicone Oils in Retinal Detachment
This study is currently recruiting participants.
Verified by Asociación para Evitar la Ceguera en México, November 2006
Sponsored by: Asociación para Evitar la Ceguera en México
Information provided by: Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier: NCT00403702
  Purpose

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
Retinal Detachment
Drug: Oxane HD [oil-RMN3-mixture]
Drug: Densiron [(F6H8)
Phase II
Phase III

U.S. FDA Resources
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

Further study details as provided by Asociación para Evitar la Ceguera en México:

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

Estimated Enrollment: 10
Study Start Date: August 2006
Estimated Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients complicated persistent retinal detachment due secondary to proliferative vitreoretinopathy

Exclusion Criteria:

  • Diabetes
  • Uveitis
  • Glaucoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403702

Contacts
Contact: Jose Luis Diaz-Rubio, MD +52 (55) 10841400 ext 1172 retinamex@yahoo.com

Locations
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            
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Study Director: Hugo Quiroz-Mercado, MD Asociacion para Evitar la Ceguera en MExico
  More Information

Publications:
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. Epub 2005 Oct 5.
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. Epub 2004 Mar 17.
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.
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.
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 Singapore. 2006 Mar;35(3):181-4.
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. French.
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.
Bhisitkul RB, Gonzalez VH. "Heavy oil" for intraocular tamponade in retinal detachment surgery. Br J Ophthalmol. 2005 Jun;89(6):649-50. No abstract available.
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.
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. Epub 2005 Jun 28.

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

Keywords provided by Asociación para Evitar la Ceguera en México:
Retinal detachment
proliferative vitreoretinopathy
heavier-than-water internal tamponades

Study placed in the following topic categories:
Retinal Detachment
Eye Diseases
Vitreoretinopathy, Proliferative
Retinal Diseases

ClinicalTrials.gov processed this record on January 14, 2009