Comparison High-density Silicone Oils in Retinal Detachment

Phase 2

Withdrawn

• Conditions: Retinal Detachment

• Registration Number: NCT00403702
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-08
• Primary Completion: 2006-08
• Study First Submitted: 2006-11-02
• Study First Submitted QC: 2006-11-24
• Study First Posted: 2006-11-27
• Study Completion: 2007-08
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients complicated persistent retinal detachment due secondary to proliferative vitreoretinopathy

Exclusion Criteria

• Diabetes
• Uveitis
• Glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
anatomical results
visual acuity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asociacion Para Evitar la Ceguera en Mexico; 🇲🇽 Mexico, D.F, Mexico