Clinical Observation of Technologic Application of No-touch Fluid-air Exchange in Surgery of Idiopathic Macula Hole

Tianjin Medical University Eye Hospital

Status: Completed

Conditions: Idiopathic Macula Hole

Treatments: Procedure: vitrectomy metrectomy and internal membrane peeling and gas tamponed; Procedure: no-touch fluid-air exchange

Study type: Interventional

Funder types: Other

Identifiers

NCT02584062

HBJ 151617

Details and patient eligibility

About

The purpose of this study is to observe the technologic application of no-touch fluid-air exchange in Surgery of Idiopathic Macula Hole.

Enrollment: 40 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients were diagnosed as having an idiopathic macular hole(IMH) by Optical Coherence Tomography(OCT).

Exclusion criteria

• Myopia of >6 diopters
• Ocular trauma and other systematic or ocular issues associated with IMHs，such as the other macula disease, for example the degeneration of macula.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

no-touch fluid-air exchange group

Experimental group

Description:

All patients in no-touch fluid-air exchange group will have a surgery of vitrectomy metrectomy and internal membrane peeling and gas tamponed.In this surgery ,investigator will not touch the macular area,especially the area of the macular hole and investigator will not have the fluid-air exchange of the macular area.

Treatment:

Procedure: vitrectomy metrectomy and internal membrane peeling and gas tamponed

Procedure: no-touch fluid-air exchange

the tradional group

Experimental group

Description:

All patients in no-touch fluid-air exchange group will have a surgery of vitrectomy metrectomy and internal membrane peeling and gas tamponed.In this surgery ,investigator will touch the macular area and investigator will have the fluid-air exchange.

Treatment:

Procedure: vitrectomy metrectomy and internal membrane peeling and gas tamponed