Comparison High-Density Silicone Oils in Retinal Detachment

June 28, 2009 updated by: Asociación para Evitar la Ceguera en México

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jose Luis Diaz-Rubio, MD
  • Phone Number: 1172 +52 (55) 10841400
  • Email: retinamex@yahoo.com

Study Locations

  • Mexico
    • D.F
      • Mexico, D.F, Mexico, 04330
        • Recruiting
        • Asociación Para Evitar la Ceguera en México
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients complicated persistent retinal detachment due secondary to proliferative vitreoretinopathy

Exclusion Criteria:

  • Diabetes
  • Uveitis
  • Glaucoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
visual acuity
anatomical results

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociación para Evitar la Ceguera en México

Investigators

  • Study Director: Hugo Quiroz-Mercado, MD, Asociación Para Evitar la Ceguera en México

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (Anticipated)

August 1, 2007

Study Registration Dates

First Submitted

November 2, 2006

First Submitted That Met QC Criteria

November 24, 2006

First Posted (Estimate)

November 27, 2006

Study Record Updates

Last Update Posted (Estimate)

June 30, 2009

Last Update Submitted That Met QC Criteria

June 28, 2009

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APEC-0021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Retinal Detachment

Clinical Trials on Oxane HD [oil-RMN3-mixture]

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe