Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
Primary Purpose
Macular Hole Retinal Detachment
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Macular Hole Retinal Detachment focused on measuring vitrectomy, macular hole retinal detachment, high myopia
Eligibility Criteria
Inclusion Criteria:
- The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane removal or inverted for macular hole retinal detachment and had followed for more than 6 months.
Exclusion Criteria:
- The patients with follow-up less than 6 months.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Inverted ILM flap group
ILM peeling group
Arm Description
Eyes underwent vitrectomy with inverted internal limiting membrane technique
Eyes underwent vitrectomy with internal limiting membrane peeling
Outcomes
Primary Outcome Measures
Visual acuity before and after surgery
Secondary Outcome Measures
Optical coherence tomography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02896972
Brief Title
Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
Official Title
Efficacy of Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyorin University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap technique for macular hole retinal detachment (MHRD) in highly myopic eyes, and to demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using swept-source optical coherence tomography (OCT)
Detailed Description
Macular hole retinal detachment (MHRD) threatens a certain number of highly myopic patients for irreversible visual dysfunction, and mostly requires immediate surgical intervention. The aim of they study is to evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap technique for MHRD in highly myopic eyes, and to demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using swept-source optical coherence tomography.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Hole Retinal Detachment
Keywords
vitrectomy, macular hole retinal detachment, high myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inverted ILM flap group
Arm Type
Active Comparator
Arm Description
Eyes underwent vitrectomy with inverted internal limiting membrane technique
Arm Title
ILM peeling group
Arm Type
Active Comparator
Arm Description
Eyes underwent vitrectomy with internal limiting membrane peeling
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy
Intervention Description
Vitrectomy with inverted ILM technique or ILM peeling
Primary Outcome Measure Information:
Title
Visual acuity before and after surgery
Time Frame
Changes from baseline to 1, 3, 6 months
Secondary Outcome Measure Information:
Title
Optical coherence tomography
Time Frame
Changes from baseline up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane removal or inverted for macular hole retinal detachment and had followed for more than 6 months.
Exclusion Criteria:
The patients with follow-up less than 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Makoto Inoue, MD
Organizational Affiliation
Kyorin Eye Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
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