Retinal Redetachment in Silicone Oil-filled EyesNCT02425085
Comparative Study of Multi-endodiathermy Retinectomy Versus Relaxing Retinectomy for Retinal Re-detachment
A study testing multi-endodiathermy retinectomy and relaxing retinectomy in people with Retinal Redetachment in Silicone Oil-filled Eyes, run by Sun Yat-sen University at 3 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Retinal Redetachment in Silicone Oil-filled Eyes
- What is being tested?
- multi-endodiathermy retinectomy and relaxing retinectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 3 sitesChina
- Study dates
- Apr 2015to Jul 2020
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
Guangzhou, Guangdong, 510000
Xiaofeng Lin, Dr, 020-87331537, linxiaof@mail.sysu.edu.cn
Xiaofeng Lin, Dr
- Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Yan Li, M.D, 0871-65324888, liyanr@hotmail.com
- Recruiting
Shenzhen Ophthalmic Center
Shenzhen, Guangdong, 518040
Bo Qin, M.D, 0755-23959600, qinbozf@163.com
About this study
Official title: Comparative Study of Multi-endodiathermy Retinectomy Versus Relaxing Retinectomy for Retinal Re-detachment in Silicone Oil Filled Eye
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.
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.
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.
- Being tested
- multi-endodiathermy retinectomy, relaxing retinectomy
- Keywords
- retinectomy, endodiathermy, inferior, retinal redetachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-endodiathermy retinectomyProcedure or surgery
patients will receive multi-endodiathermy retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.
relaxing retinectomyProcedure or surgery
patients will receive relaxing retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.
| Study group | Role | What they receive |
|---|---|---|
| multi-endodiathermy retinectomy group | Experimental | Patients receive multi-endodiathermy retinectomy Receives: Procedure: multi-endodiathermy retinectomy |
| relaxing retinectomy | Active comparator | Patients receive relaxing retinectomy Receives: Procedure: relaxing retinectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
retinal reattachment
Measured: 3 months after retinectomy
Secondary outcomes (5)
operative duration
Measured: from the end of former silicone oil removal to the end of the new silicone oil fill
visual acuity
Measured: 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
Measured: 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
Measured: during retinectomy
degree of recurrent PVR
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (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 Redetachment in Silicone Oil-filled EyesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 328 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, M.D, Principal investigator, Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425085
- Sponsor's protocol ID
- MER201504
- Status last verified
- Apr 2015
- First submitted
- 16 Apr 2015
- Last updated
- 23 Apr 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 2334327Kolomeyer AM, Grigorian RA, Mostafavi D, Bhagat N, Zarbin MA. 360 degrees retinectomy for the treatment of complex retinal detachment. Retina. 2011 Feb;31(2):266-74. doi: 10.1097/IAE.0b013e3181eef2c7.
PubMed 21124255Machemer R. [Cutting of the retina: a means of therapy for retinal reattachment (author's transl)]. Klin Monbl Augenheilkd. 1979 Nov;175(5):597-601. German.
PubMed 547089
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Multi-endodiathermy Retinectomy Versus Relaxing Retinectomy for Retinal Re-detachment in Silicone Oil Filled Eye
- ClinicalTrials.gov ID
- NCT02425085
- Acronym / sponsor ID
- MER201504
- Keywords
- retinectomy, endodiathermy, inferior, retinal redetachment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 23 Apr 2015 (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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multi-endodiathermy retinectomy group | Experimental | Procedure: multi-endodiathermy retinectomyPatients receive multi-endodiathermy retinectomy |
| relaxing retinectomy | Active comparator | Procedure: relaxing retinectomyPatients receive relaxing retinectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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-endodiathermy retinectomypatients will receive multi-endodiathermy retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil. | Procedure or surgery | multi-endodiathermy retinectomy group |
| relaxing retinectomypatients will receive relaxing retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil. | Procedure or surgery | relaxing retinectomy |
Primary outcome
retinal reattachment
Time frame: 3 months after retinectomy
5 secondary outcomes
operative duration
Time frame: from the end of former silicone oil removal to the end of the new silicone oil fill
visual acuity
Time frame: 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
Time frame: 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
Time frame: during retinectomy
degree of recurrent PVR
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 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 21124255Kolomeyer AM, Grigorian RA, Mostafavi D, Bhagat N, Zarbin MA. 360 degrees retinectomy for the treatment of complex retinal detachment. Retina. 2011 Feb;31(2):266-74. doi: 10.1097/IAE.0b013e3181eef2c7.
- Background: PubMed 547089Machemer R. [Cutting of the retina: a means of therapy for retinal reattachment (author's transl)]. Klin Monbl Augenheilkd. 1979 Nov;175(5):597-601. German.
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, M.D principal investigator
Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-endodiathermy retinectomy and relaxing retinectomy in people with Retinal Redetachment in Silicone Oil-filled Eyes, run by Sun Yat-sen University at 3 sites 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 4 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 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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, M.D (020-87331537, 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?
retinal reattachment (time frame: 3 months after retinectomy). 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 NCT02425085, 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 23 Apr 2015.