Comparative Study of Multi-endodiathermy Retinectomy Versus Relaxing Retinectomy for Retinal Re-detachment

NCT ID: NCT02425085

Last Updated: 2015-04-23

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

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

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.

Conditions

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Retinal Redetachment in Silicone Oil-filled Eyes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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multi-endodiathermy retinectomy group

Patients receive multi-endodiathermy retinectomy

Group Type EXPERIMENTAL

multi-endodiathermy retinectomy

Intervention Type PROCEDURE

patients will receive multi-endodiathermy retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.

relaxing retinectomy

Patients receive relaxing retinectomy

Group Type ACTIVE_COMPARATOR

relaxing retinectomy

Intervention Type PROCEDURE

patients will receive relaxing retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.

Interventions

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multi-endodiathermy retinectomy

patients will receive multi-endodiathermy retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.

Intervention Type PROCEDURE

relaxing retinectomy

patients will receive relaxing retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 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, M.D

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

Shenzhen Ophthalmic Center

Shenzhen, Guangdong, China

Site Status RECRUITING

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaofeng Lin, M.D

Role: CONTACT

020-87331537

Facility Contacts

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Xiaofeng Lin, Dr

Role: primary

020-87331537

Bo Qin, M.D

Role: primary

0755-23959600

Yan Li, M.D

Role: primary

0871-65324888

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)

Kolomeyer AM, Grigorian RA, Mostafavi D, Bhagat N, Zarbin MA. 360 degrees retinectomy for the treatment of complex retinal detachment. Retina. 2011 Feb;31(2):266-74. doi: 10.1097/IAE.0b013e3181eef2c7.

Reference Type BACKGROUND
PMID: 21124255 (View on PubMed)

Machemer R. [Cutting of the retina: a means of therapy for retinal reattachment (author's transl)]. Klin Monbl Augenheilkd. 1979 Nov;175(5):597-601. German.

Reference Type BACKGROUND
PMID: 547089 (View on PubMed)

Other Identifiers

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MER201504

Identifier Type: -

Identifier Source: org_study_id

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