Asymmetrical Recovery of Cone Outer Segment Tips and Fove... | NCT01959776

Studies
Asymmetrical Recovery of Cone Outer Segment Tips and Foveal Displacement After Macular Hole Surgery

NCT01959776

Sponsor

Kyorin University

Status

Completed

Last Update Posted

Oct 10, 2013Estimated

Enrollment

35Actual

Phase

Not Applicable

Conditions

Macular Hole

Interventions

Vitrectomy

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

ID	Type	Description	Link
Kyorineye013	Other Identifier	Kyorin Eye Center

Status Module

Record Verification Date

Oct 2013

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

Jul 2009

Primary Completion Date

Jul 2009Actual

Completion Date

Mar 2012Actual

First Submitted Date

Oct 7, 2013

First Submission Date that Met QC Criteria

Oct 8, 2013

First Posted Date

Oct 10, 2013Estimated

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

Oct 8, 2013

Last Update Posted Date

Oct 10, 2013Estimated

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

Evaluation of asymmetry in recovery of cone outer segment tips and foveal displacement after macular hole surgery

Detailed Description

Not provided

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

35Actual

Label	Type	Description	Intervention Names
Vitrectomy	Other		Procedure: Vitrectomy

Name	Type	Description	Arm Group Labels	Other Names
Vitrectomy	Procedure		Vitrectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Optical coherence tomography	Anatomical evaluation detected with optical coherence tomography after surgical intervention	one year

Secondary Outcomes

Measure	Description	Time Frame
Visual recovery	The numbers of the patients with visual recovery after surgical intervention	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients with macular hole

Exclusion Criteria:

The patients with follow-up less than 6 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

95 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24736052	Derived	Itoh Y, Inoue M, Rii T, Ando Y, Hirakata A. Asymmetrical recovery of cone outer segment tips line and foveal displacement after successful macular hole surgery. Invest Ophthalmol Vis Sci. 2014 May 6;55(5):3003-11. doi: 10.1167/iovs.14-13973.

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative