NCT01549249

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
333

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

Enrollment Period

2.4 years

First QC Date

March 6, 2012

Last Update Submit

November 12, 2012

Conditions

Epiretinal Membrane

Keywords

cone outer segment tips lineinner segment/outer segment junction lineoptical coherence tomographyepiretinal membrane

Outcome Measures

Primary Outcomes (1)

  • best-corrected visual acuity

    one year

Secondary Outcomes (1)

  • Integrity and defect length of the photoreceptor layer detected by spectral-domain optical coherence tomography

    one year

Study Arms (1)

vitrectomy

NO INTERVENTION
Device: optical coherence tomography

Interventions

optical coherence tomographyDEVICE

spectral-domain optical coherence tomography

Also known as: vitreous surgery
vitrectomy

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Eyes with secondary epiretinal membrane (previous history of uveitis, intraocular surgery, pre-operatively noted retinal breaks, etc.) were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyorin Eye Center

Mitaka, Tokyo, 181-8611, Japan

Location

Related Publications (1)

  • 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.

    PMID: 24106115DERIVED

MeSH Terms

Conditions

Epiretinal Membrane

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Makoto Inoue, MD

    Kyorin Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 9, 2012

Study Start

June 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2011

Last Updated

November 14, 2012

Record last verified: 2012-11

Locations

JP(1)