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Comparison High-Density Silicone Oils in Retinal Detachment
This study is currently recruiting participants.
Study NCT00403702   Information provided by Asociación para Evitar la Ceguera en México
First Received: November 2, 2006   Last Updated: June 28, 2009   History of Changes

November 2, 2006
June 28, 2009
August 2006
 
  • visual acuity
  • anatomical results
Same as current
Complete list of historical versions of study NCT00403702 on ClinicalTrials.gov Archive Site
  • complication: hypotony,
  • vitreous hemorrhage,
  • inflammatory reaction,
  • cataract,
  • chronic hypotony,
  • IOP elevated intraocular pressure,
  • pseudohypopyon,
  • fibrin,
  • emulsification droplets in the anterior chamber
Same as current
 
Comparison High-Density Silicone Oils in Retinal Detachment
Comparison of Two High-Density Silicone Oils in Complicated Rhegmatogenous Retinal Detachment

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.

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.

Phase II, Phase III
Interventional
Treatment, Randomized, Double-Blind, Historical Control, Parallel Assignment, Safety/Efficacy Study
Retinal Detachment
  • Drug: Oxane HD [oil-RMN3-mixture]
  • Drug: Densiron [(F6H8)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
10
August 2007
 

Inclusion Criteria:

  • Patients complicated persistent retinal detachment due secondary to proliferative vitreoretinopathy

Exclusion Criteria:

  • Diabetes
  • Uveitis
  • Glaucoma
Both
18 Years and older
No
Contact: Jose Luis Diaz-Rubio, MD +52 (55) 10841400 ext 1172 retinamex@yahoo.com
Mexico
 
NCT00403702
 
APEC-0021
Asociación para Evitar la Ceguera en México
 
Study Director: Hugo Quiroz-Mercado, MD Asociacion para Evitar la Ceguera en MExico
Asociación para Evitar la Ceguera en México
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP