ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Epiretinal Membrane Device: optical coherence tomography Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery
Study Start Date : June 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2011
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
No Intervention: vitrectomy Device: optical coherence tomography
spectral-domain optical coherence tomography
Other Name: vitreous surgery


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. best-corrected visual acuity [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Integrity and defect length of the photoreceptor layer detected by spectral-domain optical coherence tomography [ Time Frame: one year ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549249


Locations
Japan
Kyorin Eye Center
Mitaka, Tokyo, Japan, 181-8611
Sponsors and Collaborators
Kyorin University
Investigators
Principal Investigator: Makoto Inoue, MD Kyorin Eye Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Makoto Inoue, Associate professor, Kyorin University
ClinicalTrials.gov Identifier: NCT01549249     History of Changes
Other Study ID Numbers: KyorinEye007
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012

Keywords provided by Makoto Inoue, Kyorin University:
cone outer segment tips line
inner segment/outer segment junction line
optical coherence tomography
epiretinal membrane

Additional relevant MeSH terms:
Epiretinal Membrane
Retinal Diseases
Eye Diseases