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

Not Applicable

• Conditions: Retinal Detachment
• Interventions: Procedure: Multi-electrocoagulation retinectomy

• Registration Number: NCT02201706
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

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

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-25
• Study First Posted: 2014-07-28
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-07
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Age 5-60 years, male or female
2. The primary retinal detachment was caused by ocular trauma, and the vitreous body is filled with silicone oil now.
3. The presence of inferior retinal re-detachment located among 3-9 o'clock.

Exclusion Criteria

1. The primary retinal detachment was not caused by ocular trauma.
2. Location of the re-detached retina is not mainly in the inferior of the eye.
3. The fundus is unobservable because of severe corneal opacity.
4. The contralateral eye is non-functional
5. Serious heart, lung, liver and kidney dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multi-electrocoagulation retinectomy	Multi-electrocoagulation retinectomy	Retinal re-detachment in eyes with silicone oil filled,a modified surgery named Multi-electrocoagulation retinectomy will be used to re-attach the retina.

Primary Outcome Measures

Name	Time	Method
retina reattachment rate	3 months after the surgery

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center of Sun yat-sen Universtiy; 🇨🇳 Guangzhou, Guangdong, China