Comparison High-Density Silicone Oils in Retinal Detachment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Retinal Detachment

Intervention / Treatment
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* Drug: Oxane HD [oil-RMN3-mixture]
* Drug: Densiron [(F6H8)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients complicated persistent retinal detachment due secondary to proliferative vitreoretinopathy Exclusion Criteria: Diabetes Uveitis Glaucoma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxane HD [oil-RMN3-mixture]|nan|
|Drug: Densiron [(F6H8)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity |  |  | 
| anatomical results |  |  | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinal detachment, proliferative vitreoretinopathy, heavier-than-water internal tamponades