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

May 5, 2015 updated by: Xiaofeng Lin, Sun Yat-sen University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
        • Contact:
        • Principal Investigator:
          • Xiaofeng Lin, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Multi-electrocoagulation retinectomy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
retina reattachment rate
Time Frame: 3 months after the surgery
3 months after the surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Xiaofeng Lin, Dr, Zhongshan Ophthalmic Center of Sun yat-sen Universtiy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

July 15, 2014

First Submitted That Met QC Criteria

July 25, 2014

First Posted (Estimate)

July 28, 2014

Study Record Updates

Last Update Posted (Estimate)

May 7, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MER201407 (Other Identifier: SunYat-senU)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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