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

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:
  • vitreous surgery

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.

Publications and helpful links

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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

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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