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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Makoto Inoue, Kyorin University

ClinicalTrials.gov Identifier:

NCT01549249

First received: March 6, 2012

Last updated: November 12, 2012

Last verified: November 2012

History of Changes

Purpose

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	Intervention
Epiretinal Membrane	Device: optical coherence tomography


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery

Further study details as provided by Kyorin University:

Primary Outcome Measures:

best-corrected visual acuity [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Integrity and defect length of the photoreceptor layer detected by spectral-domain optical coherence tomography [ Time Frame: one year ] [ Designated as safety issue: No ]


Enrollment:	333
Study Start Date:	June 2008
Study Completion Date:	November 2011
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: vitrectomy	Device: optical coherence tomography spectral-domain optical coherence tomography Other Name: vitreous surgery

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

Eligibility


Ages Eligible for Study:	40 Years to 90 Years
Genders Eligible for Study:	Both
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

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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Kyorin University

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

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.


Responsible Party:	Makoto Inoue, Associate professor, Kyorin University
ClinicalTrials.gov Identifier:	NCT01549249 History of Changes
Other Study ID Numbers:	KyorinEye007
Study First Received:	March 6, 2012
Last Updated:	November 12, 2012
Health Authority:	Japan: Institutional Review Board

Keywords provided by Kyorin University:


cone outer segment tips line inner segment/outer segment junction line optical coherence tomography epiretinal membrane

Additional relevant MeSH terms:


Epiretinal Membrane Eye Diseases Retinal Diseases

ClinicalTrials.gov processed this record on March 01, 2015

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