Multi-electrocoagulation Retinectomy for Retinal Re-detachment in Silicone Oil Filled Eye

Study Overview
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Brief Summary
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Retinal re-detachment in silicone oil filled eye, especially in the traumatic eye, is a complex retinal detachment with poor prognosis. In this study, the investigators try to apply a modified surgery as Multi-electrocoagulation retinectomy to reattach the retina. Here the investigators aimed to explore the safety and efficacy of this new surgical approach

Detailed Description
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The relaxing retinectomy is a useful surgery for retinal re-detachment in eyes with silicone oil filled. However, it has some obvious disadvantages such as the cut of the normal retina surrounding, leaving a large area of retinal deficiency and significant exposure of retinal pigment epithelium and choroid membranes. In this study, we try to apply a modified surgery named Multi-electrocoagulation retinectomy to re-attach the retina. Instead of cutting through the proliferated retina directly, this new surgical approach adopts to cut the retina apart in a honeycomb shape with the help of electrocoagulation. In this way, we not only relax the traction of the proliferative membranes, but also reserve the rest retina to cover the RPE layers. Based on the hypothesis above, we are aiming to explore the safety and efficacy of this new surgical approach

Official Title
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The Explore Study for the Efficacy and Safety of Multi-electrocoagulation Retinectomy in the Treatment of Retinal Re-detachment in Silicone Oil Filled Eye

Conditions
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Retinal Detachment

Intervention / Treatment
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* Procedure: Multi-electrocoagulation retinectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 5-60 years, male or female The primary retinal detachment was caused by ocular trauma, and the vitreous body is filled with silicone oil now. The presence of inferior retinal re-detachment located among 3-9 o'clock. Exclusion Criteria: The primary retinal detachment was not caused by ocular trauma. Location of the re-detached retina is not mainly in the inferior of the eye. The fundus is unobservable because of severe corneal opacity. The contralateral eye is non-functional Serious heart, lung, liver and kidney dysfunction

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 60 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-electrocoagulation retinectomy<br>Retinal re-detachment in eyes with silicone oil filled,a modified surgery named Multi-electrocoagulation retinectomy will be used to re-attach the retina. | Procedure: Multi-electrocoagulation retinectomy<br>* a modified surgery named multi-electrocoagulation retinectomy to re-attach the retina. All the single surgical technique and devices involved in this modified surgery are used commonly in clinic. Base on this, the investigator changes the traditional sequence of these single surgical techniques, and combine them into a new surgical process.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retina reattachment rate |  | 3 months after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity |  | Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery. | 
| Intraocular pressure |  | Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery. | 
| The degree of recurrent PVR |  | Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery. | 
| The incidence of intraocular hemorrhage |  | Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinal detachment, silicone oil, retinectomy