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

NCT ID: NCT02201706

Last Updated: 2015-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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

Conditions

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Retinal Detachment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Multi-electrocoagulation retinectomy

Retinal re-detachment in eyes with silicone oil filled,a modified surgery named Multi-electrocoagulation retinectomy will be used to re-attach the retina.

Group Type EXPERIMENTAL

Multi-electrocoagulation retinectomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Xiaofeng Lin

vice-president

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaofeng Lin, Dr

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center of Sun yat-sen Universtiy

Locations

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Zhongshan Ophthalmic Center of Sun yat-sen Universtiy

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaofeng Lin, Dr

Role: CONTACT

02087330000

Facility Contacts

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Xiaofeng Lin, Dr

Role: primary

02087330000

References

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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.

Reference Type BACKGROUND
PMID: 23601479 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2334327 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18556423 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27022477 (View on PubMed)

Other Identifiers

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MER201407

Identifier Type: OTHER

Identifier Source: secondary_id

MER201407

Identifier Type: -

Identifier Source: org_study_id

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