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Comparison High-Density Silicone Oils in Retinal Detachment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00403702
Recruitment Status : Unknown
Verified November 2006 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
First Posted : November 27, 2006
Last Update Posted : June 30, 2009
Information provided by:
Asociación para Evitar la Ceguera en México

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.

Condition or disease Intervention/treatment Phase
Retinal Detachment Drug: Oxane HD [oil-RMN3-mixture] Drug: Densiron [(F6H8) Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparison of Two High-Density Silicone Oils in Complicated Rhegmatogenous Retinal Detachment
Study Start Date : August 2006
Estimated Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. visual acuity
  2. anatomical results

Secondary Outcome Measures :
  1. complication: hypotony,
  2. vitreous hemorrhage,
  3. inflammatory reaction,
  4. cataract,
  5. chronic hypotony,
  6. IOP elevated intraocular pressure,
  7. pseudohypopyon,
  8. fibrin,
  9. emulsification droplets in the anterior chamber

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients complicated persistent retinal detachment due secondary to proliferative vitreoretinopathy

Exclusion Criteria:

  • Diabetes
  • Uveitis
  • Glaucoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00403702

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Contact: Jose Luis Diaz-Rubio, MD +52 (55) 10841400 ext 1172

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Asociacion Para Evitar la Ceguera en Mexico Recruiting
Mexico, D.F, Mexico, 04330
Contact: yoko burgoa    +52 (55) 1084 1400 ext 1171   
Contact: Mariana Martinez    +52 (55) 1084 1400 ext 1171   
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
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Study Director: Hugo Quiroz-Mercado, MD Asociación para Evitar la Ceguera en México

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00403702    
Other Study ID Numbers: APEC-0021
First Posted: November 27, 2006    Key Record Dates
Last Update Posted: June 30, 2009
Last Verified: November 2006
Keywords provided by Asociación para Evitar la Ceguera en México:
Retinal detachment
proliferative vitreoretinopathy
heavier-than-water internal tamponades
Additional relevant MeSH terms:
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Retinal Detachment
Dissociative Disorders
Mental Disorders
Retinal Diseases
Eye Diseases