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

Not Applicable

Completed

• Conditions: Idiopathic Macula Hole
• Interventions: Procedure: no-touch fluid-air exchange; Procedure: vitrectomy metrectomy and internal membrane peeling and gas tamponed

• Registration Number: NCT02584062
• Lead Sponsor: Tianjin Medical University Eye Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-09
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-22
• Study Start: 2016-01-25
• Status Verified: 2018-06
• Primary Completion: 2018-06-18
• Study Completion: 2018-06-18
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no-touch fluid-air exchange group	vitrectomy metrectomy and internal membrane peeling and gas tamponed	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.
the tradional group	vitrectomy metrectomy and internal membrane peeling and gas tamponed	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.
no-touch fluid-air exchange group	no-touch fluid-air exchange	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.

Primary Outcome Measures

Name	Time	Method
the closure rate of Macular hole	six month	the closure rate of Macular hole

Trial Locations

Locations (1)

Tianjin medical university eye hosipital; 🇨🇳 Tianjin, Tianjin, China