Multi-electrocoagulation Retinectomy for Retinal Re-detachment in Silicone Oil Filled Eye

Retinal Detachment Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02201706
• Other study ID #: MER201407
• Secondary ID: MER201407
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2014
• Last updated: May 5, 2015
• Start date: October 2013
• Est. completion date: July 2017

Study information

• Verified date: May 2015
• Source: Sun Yat-sen University
• Contact: Xiaofeng Lin, Dr
• Phone: 02087330000
• Email: linxiaof[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Detachment

Intervention

Procedure:
• Multi-electrocoagulation retinectomy
a modified surgery named "multi-electrocoagulation retinectomy" to re-attach the retina. All the single surgical technique and devices involved in this modified surgery are used commonly in clinic. Base on this, the investigator changes the traditional sequence of these single surgical techniques, and combine them into a new surgical process.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center of Sun yat-sen Universtiy	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. Erratum in: Br J Ophthalmol. 2008 Aug;92(8):1159. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	retina reattachment rate		3 months after the surgery	No
Secondary	visual acuity		Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.	Yes
Secondary	Intraocular pressure		Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.	Yes
Secondary	The degree of recurrent PVR		Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.	Yes
Secondary	The incidence of intraocular hemorrhage		Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.	Yes