Retinal Redetachment in Silicone Oil-filled Eyes
Conditions
Keywords
retinectomy, endodiathermy, inferior, retinal redetachment
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.
Interventions
PROCEDUREmulti-endodiathermy retinectomy
patients will receive multi-endodiathermy retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.
PROCEDURErelaxing retinectomy
patients will receive relaxing retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| retinal reattachment | 3 months after retinectomy |
Secondary
| Measure | 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. |
| 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. |
Countries
China
Contacts
Primary ContactXiaofeng Lin, M.D
Outcome results
None listed