Retinal DetachmentNCT02201706
Multi-electrocoagulation Retinectomy for Retinal Re-detachment in Silicone Oil Filled Eye
A study testing Multi-electrocoagulation retinectomy in people with Retinal Detachment, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Multi-electrocoagulation retinectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
Guangzhou, Guangdong, 510000
Xiaofeng Lin, Dr, 02087330000, linxiaof@mail.sysu.edu.cn
Xiaofeng Lin, Dr
About this study
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
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
Read the 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
- Conditions
- Retinal Detachment
- Being tested
- Multi-electrocoagulation retinectomy
- Keywords
- Retinal detachment, silicone oil, retinectomy
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-electrocoagulation retinectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Multi-electrocoagulation retinectomy | Experimental | Retinal re-detachment in eyes with silicone oil filled,a modified surgery named Multi-electrocoagulation retinectomy will be used to re-attach the retina. Receives: Procedure: Multi-electrocoagulation retinectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
retina reattachment rate
Measured: 3 months after the surgery
Secondary outcomes (4)
visual acuity
Measured: Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.
Intraocular pressure
Measured: Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.
The degree of recurrent PVR
Measured: Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.
The incidence of intraocular hemorrhage
Measured: Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startOct 2013
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofeng Lin, Sun Yat-sen University
- Investigators
- Xiaofeng Lin, Dr, Principal investigator, Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201706
- Sponsor's protocol ID
- MER201407
- Other IDs
- MER201407
- Status last verified
- May 2015
- First submitted
- 15 Jul 2014
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23601479Han 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.
PubMed 2334327de 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.
PubMed 18556423Jiang 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.
PubMed 27022477
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02201706
- Acronym / sponsor ID
- MER201407
- Conditions
- Retinal Detachment
- Keywords
- Retinal detachment, silicone oil, retinectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-electrocoagulation retinectomy | Experimental | Procedure: Multi-electrocoagulation retinectomyRetinal re-detachment in eyes with silicone oil filled,a modified surgery named Multi-electrocoagulation retinectomy will be used to re-attach the retina. |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-electrocoagulation retinectomya 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. | Procedure or surgery | Multi-electrocoagulation retinectomy |
Primary outcome
retina reattachment rate
Time frame: 3 months after the surgery
4 secondary outcomes
visual acuity
Time frame: 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.
The degree of recurrent PVR
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
- Background: PubMed 23601479Romaniuk 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.
- Background: PubMed 2334327Han 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.
- Background: PubMed 18556423de 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.
- Derived from this study: PubMed 27022477Jiang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaofeng Lin, Dr principal investigator
Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-electrocoagulation retinectomy in people with Retinal Detachment, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaofeng Lin, Dr (02087330000, linxiaof@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retina reattachment rate (time frame: 3 months after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02201706, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2015.