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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multi-endodiathermy retinectomy group | Experimental | Patients receive multi-endodiathermy retinectomy |
|
| relaxing retinectomy | Active Comparator | Patients receive relaxing retinectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multi-endodiathermy retinectomy | Procedure | patients will receive multi-endodiathermy retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil. |
|
| Measure | Description | Time Frame |
|---|---|---|
| retinal reattachment | 3 months after retinectomy |
| Measure | Description | Time Frame |
|---|---|---|
| operative duration | from the end of former silicone oil removal to the end of the new silicone oil fill | |
| visual acuity | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaofeng Lin, M.D | Contact | 020-87331537 | linxiaof@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaofeng Lin, M.D | Zhongshan Ophthalmic Center of Sun yat-sen Universtiy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center of Sun yat-sen Universtiy | Recruiting | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23601479 | Background | 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. | |
| 2334327 | Background | 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. |
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| relaxing retinectomy | Procedure | patients will receive relaxing retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil. |
|
| intraocular pressure | 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 | during retinectomy |
| degree of recurrent PVR | 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. |
| Shenzhen Ophthalmic Center | Recruiting | Shenzhen | Guangdong | 518040 | China |
|
| First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | 650032 | China |
|
| 21124255 | Background | 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. |
| 547089 | Background | 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. |