Comparative Study of Multi-endodiathermy Retinectomy Versus Relaxing Retinectomy for Retinal Re-detachment
NCT ID: NCT02425085
Last Updated: 2015-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
328 participants
INTERVENTIONAL
2015-04-30
2020-07-31
Brief Summary
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Here, the investigators conduct this randomized and multicenter clinical trial to compare the efficacy and safety between multi-endodiathermy retinectomy and relaxing retinectomy.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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multi-endodiathermy retinectomy group
Patients receive multi-endodiathermy retinectomy
multi-endodiathermy retinectomy
patients will receive multi-endodiathermy retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.
relaxing retinectomy
Patients receive relaxing retinectomy
relaxing retinectomy
patients will receive relaxing retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.
Interventions
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multi-endodiathermy retinectomy
patients will receive multi-endodiathermy retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.
relaxing retinectomy
patients will receive relaxing retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.
Eligibility Criteria
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Inclusion Criteria
* 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 fundus is unobservable because of severe corneal opacity;
* The contralateral eye is non-functional;
* Serious heart, lung, liver and kidney dysfunction.
18 Years
60 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Xiaofeng Lin
vice-president
Principal Investigators
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Xiaofeng Lin, M.D
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
Locations
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Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
Guangzhou, Guangdong, China
Shenzhen Ophthalmic Center
Shenzhen, Guangdong, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Kolomeyer 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.
Machemer 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.
Other Identifiers
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MER201504
Identifier Type: -
Identifier Source: org_study_id
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