Multi-electrocoagulation Retinectomy for Retinal Re-detachment in Silicone Oil Filled Eye
Primary Purpose
Retinal Detachment
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Multi-electrocoagulation retinectomy
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Detachment focused on measuring Retinal detachment, silicone oil, retinectomy
Eligibility Criteria
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
Sites / Locations
- Zhongshan Ophthalmic Center of Sun yat-sen UniverstiyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multi-electrocoagulation retinectomy
Arm Description
Retinal re-detachment in eyes with silicone oil filled,a modified surgery named Multi-electrocoagulation retinectomy will be used to re-attach the retina.
Outcomes
Primary Outcome Measures
retina reattachment rate
Secondary Outcome Measures
visual acuity
Intraocular pressure
The degree of recurrent PVR
The incidence of intraocular hemorrhage
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02201706
Brief Title
Multi-electrocoagulation Retinectomy for Retinal Re-detachment in Silicone Oil Filled Eye
Official Title
The Explore Study for the Efficacy and Safety of Multi-electrocoagulation Retinectomy in the Treatment of Retinal Re-detachment in Silicone Oil Filled Eye
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
Retinal detachment, silicone oil, retinectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multi-electrocoagulation retinectomy
Arm Type
Experimental
Arm Description
Retinal re-detachment in eyes with silicone oil filled,a modified surgery named Multi-electrocoagulation retinectomy will be used to re-attach the retina.
Intervention Type
Procedure
Intervention Name(s)
Multi-electrocoagulation retinectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
retina reattachment rate
Time Frame
3 months after the surgery
Secondary Outcome Measure Information:
Title
visual acuity
Time Frame
Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.
Title
Intraocular pressure
Time Frame
Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.
Title
The degree of recurrent PVR
Time Frame
Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.
Title
The incidence of intraocular hemorrhage
Time Frame
Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaofeng Lin, Dr
Phone
02087330000
Email
linxiaof@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Lin, Dr
Organizational Affiliation
Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Lin, Dr
Phone
02087330000
Email
linxiaof@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiaofeng Lin, Dr
12. IPD Sharing Statement
Citations:
PubMed Identifier
23601479
Citation
Romaniuk VM. Ocular trauma and other catastrophes. Emerg Med Clin North Am. 2013 May;31(2):399-411. doi: 10.1016/j.emc.2013.02.003.
Results Reference
background
PubMed Identifier
2334327
Citation
Han DP, Lewis MT, Kuhn EM, Abrams GW, Mieler WF, Williams GA, Aaberg TM. Relaxing retinotomies and retinectomies. Surgical results and predictors of visual outcome. Arch Ophthalmol. 1990 May;108(5):694-7. doi: 10.1001/archopht.1990.01070070080039.
Results Reference
background
PubMed Identifier
18556423
Citation
de Silva DJ, Kwan A, Bunce C, Bainbridge J. Predicting visual outcome following retinectomy for retinal detachment. Br J Ophthalmol. 2008 Jul;92(7):954-8. doi: 10.1136/bjo.2007.131540. Epub 2008 Jun 12. Erratum In: Br J Ophthalmol. 2008 Aug;92(8):1159.
Results Reference
background
PubMed Identifier
27022477
Citation
Jiang Z, Qiu S, Lou B, Lin M, Tan J, Lin X. Radial Retinotomies with Endodiathermy for Severe Proliferative Vitreoretinopathy: Short-Term Results. J Ophthalmol. 2016;2016:2594574. doi: 10.1155/2016/2594574. Epub 2016 Feb 28.
Results Reference
derived
Learn more about this trial
Multi-electrocoagulation Retinectomy for Retinal Re-detachment in Silicone Oil Filled Eye
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