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Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery

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ClinicalTrials.gov Identifier: NCT01549249
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):
Makoto Inoue, Kyorin University

Tracking Information
First Submitted Date  ICMJE March 6, 2012
First Posted Date  ICMJE March 9, 2012
Last Update Posted Date November 14, 2012
Study Start Date  ICMJE June 2008
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2012)
best-corrected visual acuity [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2012)
Integrity and defect length of the photoreceptor layer detected by spectral-domain optical coherence tomography [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2012)
Integrity of the photoreceptor layer detected by spectral-domain optical coherence tomography [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery
Official Title  ICMJE Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Epiretinal Membrane
Intervention  ICMJE Device: optical coherence tomography
spectral-domain optical coherence tomography
Other Name: vitreous surgery
Study Arms  ICMJE No Intervention: vitrectomy
Intervention: Device: optical coherence tomography
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2012)
333
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01549249
Other Study ID Numbers  ICMJE KyorinEye007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Makoto Inoue, Kyorin University
Study Sponsor  ICMJE Kyorin University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Makoto Inoue, MD Kyorin Eye Center
PRS Account Kyorin University
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP