Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery

Study Overview
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Brief Summary
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Silicone oil has been used as a surgical tool in complicated retinal detachment surgery. There are some complications occurring in pars plana vitrectomy with silicone oil tamponade. Silicone oil emulsification is one of the complication that may result in severe sequels that are difficult to treat. It is believed that low viscosity silicone oil has more risk to develop emulsification than high viscosity silicone oil. Up to now, however, there is no conclusive guideline that which types of silicone oil is suitable for these complicated retinal detachment surgeries and what is the appropriate time to remove the oil. This prospective study aims to study the silicone oil emulsification comparing between low viscosity and high viscosity silicone oil after complicated retinal detachment surgery.

Detailed Description
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Silicone oil has been used as a surgical tool in retinal detachment surgery since 1962. The National Eye Institute Silicone Study demonstrated the superiority of silicone oil compared with sulfur hexafluoride, and its comparability with perfluoropropane, for the treatment of complicated retinal detachment associated with advanced proliferative vitreoretinopathy. There are some complications occurring in pars plana vitrectomy with silicone oil tamponade. These complications may occur during surgery and after the surgery. Silicone oil emulsification is one of the complication that may result in severe sequels including band-shaped keratopathy, complicated glaucoma and retinopathy that are difficult to treat. The commonly used silicone oil includes low viscosity and high viscosity type. It is believed that low viscosity silicone oil has more risk to develop emulsification than high viscosity silicone oil. Up to now, however, there is no conclusive guideline that which types of silicone oil is suitable for these complicated retinal detachment surgeries and what is the appropriate time to remove the oil. Retrospective medical review of these patients using 1000-vs 5000-centistoke silicone oil demonstrated that anatomic and visual acuity outcomes, as well as complication rates including emulsification, were similar in both groups. To the best of authors' knowledge, there has been no prospective study on this subject. This study aims to study the silicone oil emulsification comparing between low viscosity and high viscosity silicone oil after complicated retinal detachment surgery.

Official Title
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Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery: A Randomized Double-masked Clinical Trial

Conditions
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Retinal Detachment Rhegmatogenous

Intervention / Treatment
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* Device: Surgery using low viscosity silicone oil
* Device: Surgery using high viscosity silicone oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with diagnosis of complicated retinal detachment who underwent pars plana vitrectomy with intravitreal silicone oil tamponade Age ≥ 18 years Sign informed consent form Exclusion Criteria: Inflammatory eye diseases i.e. uveitis Corneal scar History of scleral buckling procedure History of using surfactant drugs 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low viscosity silicone oil<br>Retinal detachment surgery using low viscosity silicone oil | Device: Surgery using low viscosity silicone oil<br>* Pars plans vitrectomy using low viscosity silicone oil<br>|
| Active Comparator: high viscosity silicone oil<br>Retinal detachment surgery using high viscosity silicone oil | Device: Surgery using high viscosity silicone oil<br>* Pars plans vitrectomy using high viscosity silicone oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emulsification rate | Proportion of patients developing silicone oil emulsification in each arm/group. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retina reattachment rate | Proportion of patients having retinal reattachment after surgery in each arm/group. | 12 months | 
| visual improvement | Proportion of patients having visual improvement after surgery in each arm/group | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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silicone oil, emulsification, retinal detachment surgery