Comparative Study of Multi-endodiathermy Retinectomy Versus Relaxing Retinectomy for Retinal Re-detachment

Study Overview
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Brief Summary
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Previous pilot study has demonstrated that the novel multi-endodiathermy retinectomy is feasible, effective and safe for inferior retinal redetachments in the silicone oil-filled eyes of adults over a 3-month observation. Here, the investigators conduct this randomized and multicenter clinical trial to compare the efficacy and safety between multi-endodiathermy retinectomy and relaxing retinectomy.

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. We proposed a novel multi-endodiathermy retinectomy as a potential surgery. A pilot study has demonstrated that the novel multi-endodiathermy retinectomy is feasible, effective and safe for inferior retinal redetachments in the silicone oil-filled eyes of adults over a 3-month observation. Here, the investigators conduct this randomized and multicenter clinical trial to compare the efficacy and safety between multi-endodiathermy retinectomy and relaxing retinectomy.

Official Title
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Comparative Study of Multi-endodiathermy Retinectomy Versus Relaxing Retinectomy for Retinal Re-detachment in Silicone Oil Filled Eye

Conditions
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Retinal Redetachment in Silicone Oil-filled Eyes

Intervention / Treatment
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* Procedure: multi-endodiathermy retinectomy
* Procedure: relaxing retinectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-60 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: 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: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multi-endodiathermy retinectomy group<br>Patients receive multi-endodiathermy retinectomy | Procedure: multi-endodiathermy retinectomy<br>* patients will receive multi-endodiathermy retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.<br>|
| Active Comparator: relaxing retinectomy<br>Patients receive relaxing retinectomy | Procedure: relaxing retinectomy<br>* patients will receive relaxing retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retinal reattachment |  | 3 months after retinectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative duration |  | from the end of former silicone oil removal to the end of the new silicone oil fill | 
| visual acuity |  | 1 day before surgery; 3 days, 1 week, 2 weeks, 4 weeks and 3 months after retinectomy; 3 days, 1 week, 2 weeks, 4 weeks and 3 months after silicone oil removal. | 
| intraocular pressure |  | 1 day before surgery; 3 days, 1 week, 2 weeks, 4 weeks and 3 months after retinectomy; 3 days, 1 week, 2 weeks, 4 weeks and 3 months after silicone oil removal. | 
| the incidence of intraocular hemorrhage |  | during retinectomy | 
| degree of recurrent PVR |  | 1 day before surgery; 3 days, 1 week, 2 weeks, 4 weeks and 3 months after retinectomy; 3 days, 1 week, 2 weeks, 4 weeks and 3 months after silicone oil removal. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retinectomy, endodiathermy, inferior, retinal redetachment