Retina Projection System Trials for Low Vision People

This study has been completed.

Sponsor:

Collaborators:

Nihon University

Kurume University

Miyata Eye Hospital

Fukuoka Kinen Hospital

Kimura Eye and Medical Hospital

Information provided by:

Osaka City University

ClinicalTrials.gov Identifier:

NCT00219427

First received: September 14, 2005

Last updated: May 20, 2008

Last verified: May 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

May 20, 2008

Start Date ^ICMJE

January 2005

Primary Completion Date

November 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reading speeds with two different vision aids [ Time Frame: Visits for measuring reading speeds ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Reading speeds with two different vision aids

Change History

Complete list of historical versions of study NCT00219427 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Retina Projection System Trials for Low Vision People

Official Title ^ICMJE

Multicenter Clinical Trials of Retina Projection System

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Condition ^ICMJE

Vision, Low

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2005

Primary Completion Date

November 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

low vision patients
vision between 0.06 and 0.3

Exclusion Criteria:

light perception
hand motion
vision less than 0.06

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00219427

Other Study ID Numbers ^ICMJE

OCUM2004681, OCUM2004681

Has Data Monitoring Committee

Yes

Responsible Party

Kunihiko Shiraki, MD, Osaka City University, Dept of Ophthalmology

Study Sponsor ^ICMJE

Osaka City University

Collaborators ^ICMJE

Nihon University
Kurume University
Miyata Eye Hospital
Fukuoka Kinen Hospital
Kimura Eye and Medical Hospital

Investigators ^ICMJE

Study Director:

Kunihiko Shiraki, MD

Dept. of Ophthalmology and Visual Sciences, Osaka City University, Graduate School of Medicine

Information Provided By

Osaka City University

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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