Back to resultsSurgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes
Primary Purpose
Maculopathy, High Myopia, Surgery
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
vitrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Maculopathy focused on measuring Myopic traction maculopathy, vitrectomy, internal limiting membrane, Retrospective, case control study
Eligibility Criteria
Inclusion Criteria:
- Eyes with myopic traction maculopathy in highly myopic eyes with refractive errors ≤ -8.0 diopters and axial length ≥ 26.0 mm who underwent vitrectomy
Exclusion Criteria:
- Eyes with follow-up less than a year
Sites / Locations
- Kyorin Eye Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Myopic traction maculopathy
Arm Description
The 71 eyes of 64 patients (14 men and 50 women) with myopic traction maculopathy in highly myopic eyes (refractive errors ≤-8.0 diopters and axial length ≥26.0 mm) who underwent vitrectomy were retrospectively reviewed.
Outcomes
Primary Outcome Measures
Visual acuity
Preoperative and postoperative visual acuity
Secondary Outcome Measures
Optical coherence tomography
Anatomical retinal images by optical cohernce tomography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01658761
Brief Title
Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes
Official Title
Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2012 (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
Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was evaluated in each stage. Efficacy of internal limiting membrane was also evaluated whether it may improve visual outcome.
Detailed Description
Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was evaluated in each stage of macular retinischisis, foveal detachment, or macular hole. Efficacy of internal limiting membrane was also evaluated whether it may improve visual outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maculopathy, High Myopia, Surgery
Keywords
Myopic traction maculopathy, vitrectomy, internal limiting membrane, Retrospective, case control study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Myopic traction maculopathy
Arm Type
Experimental
Arm Description
The 71 eyes of 64 patients (14 men and 50 women) with myopic traction maculopathy in highly myopic eyes (refractive errors ≤-8.0 diopters and axial length ≥26.0 mm) who underwent vitrectomy were retrospectively reviewed.
Intervention Type
Procedure
Intervention Name(s)
vitrectomy
Other Intervention Name(s)
Myopic traction maculopathy in highly myopic eyes
Intervention Description
Surgery
Primary Outcome Measure Information:
Title
Visual acuity
Description
Preoperative and postoperative visual acuity
Time Frame
One year
Secondary Outcome Measure Information:
Title
Optical coherence tomography
Description
Anatomical retinal images by optical cohernce tomography
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eyes with myopic traction maculopathy in highly myopic eyes with refractive errors ≤ -8.0 diopters and axial length ≥ 26.0 mm who underwent vitrectomy
Exclusion Criteria:
Eyes with follow-up less than a year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Makoto Inoue, MD
Organizational Affiliation
Kyorin Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyorin Eye Center
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes
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