Optical Coherence Tomography-based Positioning for Macula... | NCT02650739

Studies
Optical Coherence Tomography-based Positioning for Macular Hole Surgery

NCT02650739

Sponsor

Kyorin University

Status

Completed

Last Update Posted

Jan 8, 2016Estimated

Enrollment

125Actual

Phase

Not provided

Conditions

Macular Hole Surgery

Interventions

Macular hole surgery

Countries

Not provided

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

Jan 2016

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

May 2013

Primary Completion Date

Aug 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Jan 6, 2016

First Submission Date that Met QC Criteria

Jan 6, 2016

First Posted Date

Jan 8, 2016Estimated

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

Jan 6, 2016

Last Update Posted Date

Jan 8, 2016Estimated

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

Detailed Description

The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared with the surgery by the surgeon's decision. All eyes were treated by pars plana vitrectomy, internal limiting membrane peeling, and gas tamponade. MH closure was defined as a connection of the edges of the sensory retina in the SS-OCT images.The macular hole closure and visual outcome were compared.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

125Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SS-OCTdetermined group		Eyes with macular hole surgery that the postoperative prone positioning was discontinued after detecting a closure by SS-OCT	Procedure: Macular hole surgery
Control group		Eyes with macular hole surgery that the halting of the prone position was determined by the surgeon	Procedure: Macular hole surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Macular hole surgery	Procedure	Vitrectomy with internal limiting membrane removal and gas tamponade	Control group SS-OCTdetermined group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Macular hole closure	Closure of macular hole	Changes from baseline to 1, 2 months

Secondary Outcomes

Measure	Description	Time Frame
Visual acuity before and after surgery	Vision	Changes from baseline to 1, 2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients were followed more than 2 months.

Exclusion Criteria:

Eye with axial length more than 26.0 mm

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images in 60 eyes was compared with the 69 eyes with same surgical procedure but the prone position determined by the surgeon's decision.

Sampling Method

Non-Probability Sample

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014821	Vitrectomy

Ancestor Terms

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

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Browse Branches

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