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Comparison High-density Silicone Oils in Retinal Detachment

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

Status
Withdrawn
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00403702
Enrollment
0
Registered
2006-11-27
Start date
2006-08-31
Completion date
2007-08-31
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Detachment

Keywords

Retinal detachment, proliferative vitreoretinopathy, heavier-than-water internal tamponades

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.

Interventions

DRUGOxane HD [oil-RMN3-mixture]
DRUGDensiron [(F6H8)

Sponsors

Asociación para Evitar la Ceguera en México
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients complicated persistent retinal detachment due secondary to proliferative vitreoretinopathy

Exclusion criteria

* Diabetes * Uveitis * Glaucoma

Design outcomes

Primary

MeasureTime frame
visual acuity
anatomical results

Secondary

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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026