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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
  Purpose

  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

Condition
Vision, Low

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multicenter Clinical Trials of Retina Projection System

Resource links provided by NLM:

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U.S. FDA Resources

Further study details as provided by Osaka City University:

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

Enrollment: 58
Study Start Date: January 2005
Study Completion Date: December 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)

Detailed 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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  • low vision patients
  • vision between 0.06 and 0.3

Exclusion Criteria:

  • light perception
  • hand motion
  • vision less than 0.06
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219427

Locations
Japan
Kurume University
Kurume, Fukuoka, Japan, 830-0011
Kimura Eye and Medical Hospital
Kure, Hiroshima, Japan, 737-0046
Miyata Eye Hospital
Miyakonojo, Miyazaki, Japan, 885-0051
Fukuoka Kinen Hospital
Fukuoka, Japan, 814-8525
Osaka City University
Osaka, Japan, 545-8585
Nihon University Surugadai Hospital
Tokyo, Japan, 101-8309
Sponsors and Collaborators
Osaka City University
Nihon University
Kurume University
Miyata Eye Hospital
Fukuoka Kinen Hospital
Kimura Eye and Medical Hospital
Investigators
Study Director: Kunihiko Shiraki, MD Dept. of Ophthalmology and Visual Sciences, Osaka City University, Graduate School of Medicine
  More Information

No publications provided

Responsible Party: Kunihiko Shiraki, MD, Osaka City University, Dept of Ophthalmology
ClinicalTrials.gov Identifier: NCT00219427     History of Changes
Other Study ID Numbers: OCUM2004681, OCUM2004681
Study First Received: September 14, 2005
Last Updated: May 20, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Osaka City University:
Low vision

Additional relevant MeSH terms:
Vision, Low
Vision Disorders
Sensation Disorders
Neurologic Manifestations
 Nervous System Diseases
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013