Retina Projection System Trials for Low Vision People

Vision, Low Clinical Trial

Official title:

Multicenter Clinical Trials of Retina Projection System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219427
• Other study ID #: OCUM2004681
• Secondary ID: OCUM2004681
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: May 20, 2008
• Start date: January 2005
• Est. completion date: December 2005

Study information

• Verified date: May 2008
• Source: Osaka City University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial Summary

1. Purpose

a. Examination on Efficacy of Retina Projection System

2. Patients

a. Low vision patients

3. Methods

1. Vision aids

• Retina Projection System

• Face-mounted video display as control

2. Comparison of Reading Speeds with both vision aids

Description:

1. Purpose

a. Examination on efficacy of a new vision aid of Retina Projection System

2. Patients

1. Low vision patients

2. Vision between 0.06 and 0.3

3. no exclusion on kinds of ocular diseases

3. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• low vision patients

• vision between 0.06 and 0.3

Exclusion Criteria:

• light perception

• hand motion

• vision less than 0.06

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Vision, Low

Locations

Country	Name	City	State
Japan	Fukuoka Kinen Hospital	Fukuoka
Japan	Kimura Eye and Medical Hospital	Kure	Hiroshima
Japan	Kurume University	Kurume	Fukuoka
Japan	Miyata Eye Hospital	Miyakonojo	Miyazaki
Japan	Osaka City University	Osaka
Japan	Nihon University Surugadai Hospital	Tokyo

Sponsors (6)

Lead Sponsor	Collaborator
Osaka City University	Fukuoka Kinen Hospital, Kimura Eye and Internal Medicine Hospital, Kurume University, Miyata Eye Hospital, Nihon University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reading speeds with two different vision aids		Visits for measuring reading speeds	No