Evaluation of the Cone Outer Segment Tips Line After Epir... | NCT01549249

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

NCT01549249

Sponsor

Kyorin University

Status

Completed

Last Update Posted

Nov 14, 2012Estimated

Enrollment

333Actual

Phase

Not Applicable

Conditions

Epiretinal Membrane

Interventions

optical coherence tomography

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2011Actual

First Submitted Date

Mar 6, 2012

First Submission Date that Met QC Criteria

Mar 8, 2012

First Posted Date

Mar 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2012

Last Update Posted Date

Nov 14, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

333Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vitrectomy	No Intervention		Device: optical coherence tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
optical coherence tomography	Device	spectral-domain optical coherence tomography	vitrectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
best-corrected visual acuity		one year

Secondary Outcomes

Measure	Description	Time Frame
Integrity and defect length of the photoreceptor layer detected by spectral-domain optical coherence tomography		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Makoto Inoue, MD	Kyorin Eye Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyorin Eye Center		Mitaka	Tokyo	181-8611	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24106115	Derived	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.

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

ID	Term
D041622	Tomography, Optical
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures