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

Sun Yat-sen University

Status: Unknown

Conditions: Retinal Redetachment in Silicone Oil-filled Eyes

Treatments: Procedure: relaxing retinectomy; Procedure: multi-endodiathermy retinectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02425085

MER201504

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment: 328 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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328 participants in 2 patient groups

multi-endodiathermy retinectomy group

Experimental group

Description:

Patients receive multi-endodiathermy retinectomy

Treatment:

Procedure: multi-endodiathermy retinectomy

relaxing retinectomy

Active Comparator group

Description:

Patients receive relaxing retinectomy

Treatment:

Procedure: relaxing retinectomy