Ultrastructure Analysis of Excised Internal Limiting Memb... | NCT02528058

Studies
Ultrastructure Analysis of Excised Internal Limiting Membrane in Eyes of Highly Myopia With Myopic Traction Maculopathy

NCT02528058

Sponsor

Kyorin University

Status

Completed

Last Update Posted

Aug 19, 2015Estimated

Enrollment

7Actual

Phase

Not provided

Conditions

Myopic Traction Maculopathy

Interventions

Vitrectomy with internal limiting membrane peeling

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

Aug 2015

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 2010

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2015Actual

First Submitted Date

Aug 16, 2015

First Submission Date that Met QC Criteria

Aug 17, 2015

First Posted Date

Aug 19, 2015Estimated

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

Aug 17, 2015

Last Update Posted Date

Aug 19, 2015Estimated

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 excised ILM from 7 eyes of 7 patients with MTM including 7 eyes with macular retinoschisis and 4 eyes with foveal detachment but without any retinal break underwent vitrectomy with induction of posterior vitreous detachment and ILM peeling was examined to evaluate ultrastructure with electron microscopy.

Detailed Description

Not provided

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

Retention

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Myopic traction maculopathy			Procedure: Vitrectomy with internal limiting membrane peeling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitrectomy with internal limiting membrane peeling	Procedure		Myopic traction maculopathy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity before and after surgery	Comparison in logarithm of Minimum Angle of Resolution (logMAR) vision	6 months

Secondary Outcomes

Measure	Description	Time Frame
Retinal reattachment	Resolution of macular retinoschisis and foveal detachment	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane peeling for myopic traction maculopathy and had a follow-up for more than 6 months.

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

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

The patients who underwent vitrectomy with internal limiting membrane peeling for myopic traction maculopathy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Akito Hirakata, MD	Kyorin Eye Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Makoto Inoue		Mitaka	Tokyo	181-8611	Japan

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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