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

Primary Purpose

Idiopathic Macula Hole

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
no-touch fluid-air exchange
vitrectomy metrectomy and internal membrane peeling and gas tamponed
Sponsored by
Tianjin Medical University Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Macula Hole

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tianjin medical university eye hosipital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

no-touch fluid-air exchange group

the tradional group

Arm 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.

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.

Outcomes

Primary Outcome Measures

the closure rate of Macular hole
the closure rate of macular hole through OCT
the closure rate of Macular hole
the closure rate of Macular hole
the closure rate of Macular hole
the closure rate of Macular hole

Secondary Outcome Measures

Full Information

First Posted
October 9, 2015
Last Updated
June 18, 2018
Sponsor
Tianjin Medical University Eye Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02584062
Brief Title
Clinical Observation of Technologic Application of No-touch Fluid-air Exchange in Surgery of Idiopathic Macula Hole
Official Title
The Eye Hospital of Tianjin Medical University
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 25, 2016 (Actual)
Primary Completion Date
June 18, 2018 (Actual)
Study Completion Date
June 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University Eye Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Macula Hole

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no-touch fluid-air exchange group
Arm Type
Experimental
Arm 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.
Arm Title
the tradional group
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
no-touch fluid-air exchange
Other Intervention Name(s)
vitrectomy metrectomy and internal membrane peeling and gas tamponed
Intervention Type
Procedure
Intervention Name(s)
vitrectomy metrectomy and internal membrane peeling and gas tamponed
Primary Outcome Measure Information:
Title
the closure rate of Macular hole
Description
the closure rate of macular hole through OCT
Time Frame
one month
Title
the closure rate of Macular hole
Description
the closure rate of Macular hole
Time Frame
three month
Title
the closure rate of Macular hole
Description
the closure rate of Macular hole
Time Frame
six month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tianjin medical university eye hosipital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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