Retina Projection System Trials for Low Vision People | NCT00219427

Studies
Retina Projection System Trials for Low Vision People

NCT00219427

Sponsor

Osaka City University

Status

Completed

Last Update Posted

May 22, 2008Estimated

Enrollment

58Actual

Phase

Not provided

Conditions

Vision, Low

Interventions

Not provided

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
OCUM2004681

Status Module

Record Verification Date

May 2008

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

Jan 2005

Primary Completion Date

Nov 2005Actual

Completion Date

Dec 2005Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 22, 2005Estimated

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

May 20, 2008

Last Update Posted Date

May 22, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Osaka City UniversityOTHER

Collaborators

Name	Class
Nihon University	OTHER
Kurume University	OTHER
Miyata Eye Hospital	UNKNOWN
Fukuoka Kinen Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Purpose

a. Examination on Efficacy of Retina Projection System
Patients

a. Low vision patients
Methods
1. Vision aids
  - Retina Projection System
  - Face-mounted video display as control
2. Comparison of Reading Speeds with both vision aids

Detailed Description

Purpose

a. Examination on efficacy of a new vision aid of Retina Projection System
Patients
1. Low vision patients
2. Vision between 0.06 and 0.3
3. no exclusion on kinds of ocular diseases
Methods
1. Vision aids
  - Retina Projection System
  - Face-mounted video display as control
2. Computer-aided measurement of reading speeds of individual characters
3. Comparison of reading Speeds with the two vision aids

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Label	Type	Description	Intervention Names
1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reading speeds with two different vision aids		Visits for measuring reading speeds

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

low vision patients
vision between 0.06 and 0.3

Exclusion Criteria:

light perception
hand motion
vision less than 0.06

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kunihiko Shiraki, MD	Dept. of Ophthalmology and Visual Sciences, Osaka City University, Graduate School of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fukuoka Kinen Hospital		Fukuoka	Fukuoka	814-8525	Japan
Kurume University

Condition Browse Module

MeSH Terms

ID	Term
D015354	Vision, Low

Ancestor Terms

ID	Term
D014786	Vision Disorders
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided