NCT02201706

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 28, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

3.8 years

First QC Date

July 15, 2014

Last Update Submit

May 5, 2015

Conditions

Retinal Detachment

Keywords

Retinal detachmentsilicone oilretinectomy

Outcome Measures

Primary Outcomes (1)

  • retina reattachment rate

    3 months after the surgery

Secondary Outcomes (4)

  • visual acuity

    Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.

  • Intraocular pressure

    Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.

  • The degree of recurrent PVR

    Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.

  • The incidence of intraocular hemorrhage

    Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.

Study Arms (1)

Multi-electrocoagulation retinectomy

EXPERIMENTAL

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

Procedure: Multi-electrocoagulation retinectomy

Interventions

Multi-electrocoagulation retinectomyPROCEDURE

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.

Multi-electrocoagulation retinectomy

Eligibility Criteria

Age5 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 5-60 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.

You may not qualify if:

  • The primary retinal detachment was not caused by ocular trauma.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center of Sun yat-sen Universtiy

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 23601479BACKGROUND

  • 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.

    PMID: 2334327BACKGROUND

  • 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.

    PMID: 18556423BACKGROUND

  • 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.

    PMID: 27022477DERIVED

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Xiaofeng Lin, Dr

    Zhongshan Ophthalmic Center of Sun yat-sen Universtiy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaofeng Lin, Dr

CONTACT

02087330000linxiaof@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice-president

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 28, 2014

Study Start

October 1, 2013

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

May 7, 2015

Record last verified: 2015-05

Locations

CN(1)