- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01549249
Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery
November 12, 2012 updated by: Makoto Inoue, Kyorin University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
333
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tokyo
-
Mitaka, Tokyo, Japan, 181-8611
- Kyorin Eye Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: vitrectomy
|
spectral-domain optical coherence tomography
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
best-corrected visual acuity
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Integrity and defect length of the photoreceptor layer detected by spectral-domain optical coherence tomography
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
March 6, 2012
First Submitted That Met QC Criteria
March 8, 2012
First Posted (Estimate)
March 9, 2012
Study Record Updates
Last Update Posted (Estimate)
November 14, 2012
Last Update Submitted That Met QC Criteria
November 12, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KyorinEye007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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