Clinical Trial: Comparison High-Density Silicone Oils in Retinal Detachment

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Comparison of Two High-Density Silicone Oils in Complicated Rhegmatogenous Retinal Detachment

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 Summary:

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.


Sponsor: Asociación para Evitar la Ceguera en México

Current Primary Outcome:

  • visual acuity
  • anatomical results


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • complication: hypotony,
  • vitreous hemorrhage,
  • inflammatory reaction,
  • cataract,
  • chronic hypotony,
  • IOP elevated intraocular pressure,
  • pseudohypopyon,
  • fibrin,
  • emulsification droplets in the anterior chamber


Original Secondary Outcome: Same as current

Information By: Asociación para Evitar la Ceguera en México

Dates:
Date Received: November 2, 2006
Date Started: August 2006
Date Completion: August 2007
Last Updated: June 28, 2009
Last Verified: November 2006