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

NCT ID: NCT02584062

Last Updated: 2018-06-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-25

Study Completion Date

2018-06-18

Brief Summary

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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

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Conditions

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Idiopathic Macula Hole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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no-touch fluid-air exchange group

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.

Group Type EXPERIMENTAL

no-touch fluid-air exchange

Intervention Type PROCEDURE

vitrectomy metrectomy and internal membrane peeling and gas tamponed

Intervention Type PROCEDURE

the tradional group

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.

Group Type EXPERIMENTAL

vitrectomy metrectomy and internal membrane peeling and gas tamponed

Intervention Type PROCEDURE

Interventions

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no-touch fluid-air exchange

Intervention Type PROCEDURE

vitrectomy metrectomy and internal membrane peeling and gas tamponed

Intervention Type PROCEDURE

Other Intervention Names

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vitrectomy metrectomy and internal membrane peeling and gas tamponed

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bojie Hu

Head of Ophthalmology department, Principal Investigator, Associate Senior Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tianjin medical university eye hosipital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Other Identifiers

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HBJ 151617

Identifier Type: -

Identifier Source: org_study_id

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