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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
328
patients will receive multi-endodiathermy retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.
patients will receive relaxing retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.
Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
Guangzhou, Guangdong, China
RECRUITINGShenzhen Ophthalmic Center
Shenzhen, Guangdong, China
RECRUITINGFirst Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
RECRUITINGretinal reattachment
Time frame: 3 months after retinectomy
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.