Clinical trial NCT02425085: Comparative Study of Multi-endodiathermy Retinectomy Versus Relaxing Retinectomy for Retinal Re-detachment
Official title: Comparative Study of Multi-endodiathermy Retinectomy Versus Relaxing Retinectomy for Retinal Re-detachment in Silicone Oil Filled Eye
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Redetachment in Silicone Oil-filled Eyes
Keywords: retinectomy
endodiathermy
inferior
retinal redetachment
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: retinal reattachment
timeFrame: 3 months after retinectomy
Secondary outcomes:
measure: operative duration
timeFrame: from the end of former silicone oil removal to the end of the new silicone oil fill
measure: visual acuity
timeFrame: 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.
measure: intraocular pressure
timeFrame: 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.
measure: the incidence of intraocular hemorrhage
timeFrame: during retinectomy
measure: degree of recurrent PVR
timeFrame: 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.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Ophthalmic Center
state: Guangdong
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
name: Xiaofeng Lin, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
citation: 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.