Macular Retinoschisis and Detachment Associated With Glau... | NCT01862627

Studies
Macular Retinoschisis and Detachment Associated With Glaucomatous Optic Neuropathy

NCT01862627

Sponsor

Kyorin University

Status

Completed

Last Update Posted

Aug 20, 2014Estimated

Enrollment

11Actual

Phase

Not provided

Conditions

Macular Retinoschisis
Macular Detachment
Normal Tension Glaucoma

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

Aug 2014

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

Dec 2004

Primary Completion Date

Apr 2013Actual

Completion Date

Not provided

First Submitted Date

May 15, 2013

First Submission Date that Met QC Criteria

May 23, 2013

First Posted Date

May 24, 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

Aug 18, 2014

Last Update Posted Date

Aug 20, 2014Estimated

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

Clinical features, optical coherence tomography findings and surgical outcome in eyes with macular retinoschisis and detachment with normal tension glaucoma but without optic disc pit or high myopia were evaluated.

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

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Macular retinoschisis and detachment			Procedure: Optical coherence tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optical coherence tomography	Procedure		Macular retinoschisis and detachment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Optical coherence tomography	Anatomical improvement detected with optical coherence tomography after surgical intervention.	One year

Secondary Outcomes

Measure	Description	Time Frame
Visual recovery	The number 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 retinoschisis and detachment associated with normal tension glaucoma

Exclusion Criteria:

Optic pit maculopathy, high myopia

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

The patients with macular retinoschisis and detachment associated with normal tension glaucoma

Sampling Method

Probability Sample

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

Condition Browse Module

MeSH Terms

ID	Term
D057066	Low Tension Glaucoma

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases
D009901	Optic Nerve Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D041623	Tomography, Optical Coherence

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided