Clinical trial NCT02201706: Multi-electrocoagulation Retinectomy for Retinal Re-detachment in Silicone Oil Filled Eye
Official title: The Explore Study for the Efficacy and Safety of Multi-electrocoagulation Retinectomy in the Treatment of Retinal Re-detachment in Silicone Oil Filled Eye
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Detachment
Keywords: Retinal detachment
silicone oil
retinectomy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-07-28
Enrollment: 9
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Retinal re-detachment in silicone oil filled eye, especially in the traumatic eye, is a complex retinal detachment with poor prognosis.

In this study, the investigators try to apply a modified surgery as Multi-electrocoagulation retinectomy to reattach the retina. Here the investigators aimed to explore the safety and efficacy of this new surgical approach

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.

In this study, we try to apply a modified surgery named Multi-electrocoagulation retinectomy to re-attach the retina.

Instead of cutting through the proliferated retina directly, this new surgical approach adopts to cut the retina apart in a honeycomb shape with the help of electrocoagulation.

In this way, we not only relax the traction of the proliferative membranes, but also reserve the rest retina to cover the RPE layers.

Based on the hypothesis above, we are aiming to explore the safety and efficacy of this new surgical approach

Eligibility criteria: Inclusion Criteria:

1. Age 5-60 years, male or female
2. The primary retinal detachment was caused by ocular trauma, and the vitreous body is filled with silicone oil now.
3. The presence of inferior retinal re-detachment located among 3-9 o'clock.

Exclusion Criteria:

1. The primary retinal detachment was not caused by ocular trauma.
2. Location of the re-detached retina is not mainly in the inferior of the eye.
3. The fundus is unobservable because of severe corneal opacity.
4. The contralateral eye is non-functional
5. Serious heart, lung, liver and kidney dysfunction

Primary outcomes:
measure: retina reattachment rate
timeFrame: 3 months after the surgery
Secondary outcomes:
measure: visual acuity
timeFrame: Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.
measure: Intraocular pressure
timeFrame: Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.
measure: The degree of recurrent PVR
timeFrame: Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.
measure: The incidence of intraocular hemorrhage
timeFrame: Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
name: Xiaofeng Lin, Dr
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: de Silva DJ, Kwan A, Bunce C, Bainbridge J. Predicting visual outcome following retinectomy for retinal detachment. Br J Ophthalmol. 2008 Jul;92(7):954-8. doi: 10.1136/bjo.2007.131540. Epub 2008 Jun 12.
citation: Jiang Z, Qiu S, Lou B, Lin M, Tan J, Lin X. Radial Retinotomies with Endodiathermy for Severe Proliferative Vitreoretinopathy: Short-Term Results. J Ophthalmol. 2016;2016:2594574. doi: 10.1155/2016/2594574. Epub 2016 Feb 28.