Back to resultsEvaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery
Primary Purpose
Epiretinal Membrane
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
optical coherence tomography
Sponsored by
About this trial
This is an interventional treatment trial for Epiretinal Membrane focused on measuring cone outer segment tips line, inner segment/outer segment junction line, optical coherence tomography, epiretinal membrane
Eligibility Criteria
Inclusion Criteria:
- Patients who received epiretinal membrane surgery between June, 2008, and November, 2010, at Kyorin Eye Center.
- Only eyes with postoperative follow-up period more than 6 months were included.
Exclusion Criteria:
- Eyes with secondary epiretinal membrane (previous history of uveitis, intraocular surgery, pre-operatively noted retinal breaks, etc.) were excluded.
Sites / Locations
- Kyorin Eye Center
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
vitrectomy
Arm Description
Outcomes
Primary Outcome Measures
best-corrected visual acuity
Secondary Outcome Measures
Integrity and defect length of the photoreceptor layer detected by spectral-domain optical coherence tomography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01549249
Brief Title
Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery
Official Title
Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 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
The recovery of the cone outer segment tips (COST) line after epiretinal membrane (ERM) surgery using spectral-domain optical coherence tomography (SD-OCT) was assessed.
Detailed Description
Epiretinal membrane (ERM) may cause decreased central vision or metamorphopsia. Pars plana vitrectomy with membrane peeling has become the standard treatment for epiretinal membrane. However, visual recovery or symptomatic relief is not always satisfactory in all eyes despite successful membrane removal. Spectral domain optical coherence tomography (SD-OCT) is a non-invasive imaging device for various vitreoretinal diseases. Cone outer segment tips (COST) line is a line observed between IS/OS line and RPE in SD-OCT. The investigators examined the correlation of visual acuity and the recovery of photoreceptor layer after ERM surgery, taking COST line into account as a new parameter
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane
Keywords
cone outer segment tips line, inner segment/outer segment junction line, optical coherence tomography, epiretinal membrane
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
333 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitrectomy
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
optical coherence tomography
Other Intervention Name(s)
vitreous surgery
Intervention Description
spectral-domain optical coherence tomography
Primary Outcome Measure Information:
Title
best-corrected visual acuity
Time Frame
one year
Secondary Outcome Measure Information:
Title
Integrity and defect length of the photoreceptor layer detected by spectral-domain optical coherence tomography
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who received epiretinal membrane surgery between June, 2008, and November, 2010, at Kyorin Eye Center.
Only eyes with postoperative follow-up period more than 6 months were included.
Exclusion Criteria:
Eyes with secondary epiretinal membrane (previous history of uveitis, intraocular surgery, pre-operatively noted retinal breaks, etc.) were excluded.
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
Citations:
PubMed Identifier
24106115
Citation
Itoh Y, Inoue M, Rii T, Hirota K, Hirakata A. Correlation between foveal cone outer segment tips line and visual recovery after epiretinal membrane surgery. Invest Ophthalmol Vis Sci. 2013 Nov 5;54(12):7302-8. doi: 10.1167/iovs.13-12702.
Results Reference
derived
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Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery
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