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Comparison High-Density Silicone Oils in Retinal Detachment

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ClinicalTrials.gov 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
Sponsor:
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.


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

U.S. FDA Resources




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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00403702


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

Locations
Mexico
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 Asociación para Evitar la Ceguera en México

Publications:

ClinicalTrials.gov Identifier: NCT00403702     History of Changes
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:
Dissociative Disorders
Retinal Detachment
Mental Disorders
Retinal Diseases
Eye Diseases