Back to resultsFoveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery
Primary Purpose
Macular Holes
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Vitreous surgery for macular hole
Sponsored by
About this trial
This is an interventional treatment trial for Macular Holes focused on measuring spectral-domain optical coherence tomography, idiopathic macular hole, cone outer segment tips line, vitrectomy
Eligibility Criteria
Inclusion Criteria:
- macular hole patients with surgically-closed hole
Exclusion Criteria:
- macular hole patients failed to close hole
- presence of retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy, and high myopia with an axial length >27.0mm or refractive error > -8.0 diopters(D).
- patients who were not followed at least 6 months
Sites / Locations
- Makoto Inoue
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Eyes with macular hole
Arm Description
Outcomes
Primary Outcome Measures
Visual acuity
Preoperative, postoperative 1, 3, 6, 9, 12 months
Secondary Outcome Measures
Integrity of cone outer segment tips line
The mean length of cone outer segment tips defect on preoperative and postoperative 1, 3, 6, 9, and 12 months with spectral domain optical coherence tomography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01381965
Brief Title
Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery
Official Title
Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2011 (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
Spectral domain optical coherence tomography (SD-OCT) was used to determine whether the repair of photoreceptor cone outer segment tips defect is significantly correlated with the visual outcomes after macular hole surgery.
Detailed Description
Spectral domain optical coherence tomography (SD-OCT) was used to calculate the mean length of photoreceptor cone outer segment tips (COST) defect on 1, 3, 6, 9, and 12 months after macular hole surgery. The correlation between the mean length of COST defect and the BCVA was determined. Prognostic factors might have influenced for COST repair was also evaluated by multivariable analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes
Keywords
spectral-domain optical coherence tomography, idiopathic macular hole, cone outer segment tips line, vitrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eyes with macular hole
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Vitreous surgery for macular hole
Intervention Description
Vitreous surgery for macular hole
Primary Outcome Measure Information:
Title
Visual acuity
Description
Preoperative, postoperative 1, 3, 6, 9, 12 months
Time Frame
one year
Secondary Outcome Measure Information:
Title
Integrity of cone outer segment tips line
Description
The mean length of cone outer segment tips defect on preoperative and postoperative 1, 3, 6, 9, and 12 months with spectral domain optical coherence tomography
Time Frame
one year
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:
macular hole patients with surgically-closed hole
Exclusion Criteria:
macular hole patients failed to close hole
presence of retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy, and high myopia with an axial length >27.0mm or refractive error > -8.0 diopters(D).
patients who were not followed at least 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
Facility Information:
Facility Name
Makoto Inoue
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
12. IPD Sharing Statement
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Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery
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