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Comparison High-density Silicone Oils in Retinal Detachment

A

Asociación para Evitar la Ceguera en México

Status and phase

Withdrawn
Phase 3
Phase 2

Conditions

Retinal Detachment

Treatments

Drug: Densiron [(F6H8)
Drug: Oxane HD [oil-RMN3-mixture]

Study type

Interventional

Funder types

Other

Identifiers

NCT00403702
APEC-0021

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients complicated persistent retinal detachment due secondary to proliferative vitreoretinopathy

Exclusion criteria

  • Diabetes
  • Uveitis
  • Glaucoma

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Jose Luis Diaz-Rubio, MD

Data sourced from clinicaltrials.gov

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