The Eye Hospital of Tianjin Medical University
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- the closure rate of Macular hole
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: no-touch fluid-air exchange (Procedure)
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.
Intervention: vitrectomy metrectomy and internal membrane peeling and gas tamponed (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.
Intervention: vitrectomy metrectomy and internal membrane peeling and gas tamponed (Procedure)
Outcomes
Primary Outcomes
the closure rate of Macular hole
Time Frame: six month
the closure rate of Macular hole
Secondary Outcomes
No secondary outcomes reported
Investigators
Bojie Hu
Head of Ophthalmology department, Principal Investigator, Associate Senior Physician
Tianjin Medical University Eye Hospital