Back to resultsAsymmetrical Recovery of Cone Outer Segment Tips and Foveal Displacement After Macular Hole Surgery
Primary Purpose
Macular Hole
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Vitrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Macular Hole focused on measuring cone outer segment tips line, foveal displacement
Eligibility Criteria
Inclusion Criteria:
- The patients with macular hole
Exclusion Criteria:
- The patients with follow-up less than 6 months
Sites / Locations
- Kyorin Eye Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Vitrectomy
Arm Description
Outcomes
Primary Outcome Measures
Optical coherence tomography
Anatomical evaluation detected with optical coherence tomography after surgical intervention
Secondary Outcome Measures
Visual recovery
The numbers of the patients with visual recovery after surgical intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01959776
Brief Title
Asymmetrical Recovery of Cone Outer Segment Tips and Foveal Displacement After Macular Hole Surgery
Official Title
Asymmetrical Recovery of Cone Outer Segment Tips and Foveal Displacement After Macular Hole Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2009 (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
Evaluation of asymmetry in recovery of cone outer segment tips and foveal displacement after macular hole surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Hole
Keywords
cone outer segment tips line, foveal displacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitrectomy
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy
Primary Outcome Measure Information:
Title
Optical coherence tomography
Description
Anatomical evaluation detected with optical coherence tomography after surgical intervention
Time Frame
one year
Secondary Outcome Measure Information:
Title
Visual recovery
Description
The numbers of the patients with visual recovery after surgical intervention
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients with macular hole
Exclusion Criteria:
The patients with follow-up less than 6 months
Facility Information:
Facility Name
Kyorin Eye Center
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24736052
Citation
Itoh Y, Inoue M, Rii T, Ando Y, Hirakata A. Asymmetrical recovery of cone outer segment tips line and foveal displacement after successful macular hole surgery. Invest Ophthalmol Vis Sci. 2014 May 6;55(5):3003-11. doi: 10.1167/iovs.14-13973.
Results Reference
derived
Learn more about this trial
Asymmetrical Recovery of Cone Outer Segment Tips and Foveal Displacement After Macular Hole Surgery
We'll reach out to this number within 24 hrs