Vision, LowNCT00219427
Retina Projection System Trials for Low Vision People
An observational study of Vision, Low, run by Osaka City University at 6 sites in Japan.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vision, Low
- How many people
- 58 participants
- Where
- 6 sitesJapan
- Study dates
- Jan 2005to Dec 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- low vision patients
- vision between 0.06 and 0.3
Who cannot join
- light perception
- hand motion
- vision less than 0.06
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Fukuoka Kinen Hospital
Fukuoka, Fukuoka, 814-8525
Kimura Eye and Medical Hospital
Kure, Hiroshima, 737-0046
Kurume University
Kurume, Fukuoka, 830-0011
Miyata Eye Hospital
Miyakonojō, Miyazaki, 885-0051
Osaka City University
Osaka, Osaka, 545-8585
Nihon University Surugadai Hospital
Tokyo, Tokyo, 101-8309
About this study
Official title: Multicenter Clinical Trials of Retina Projection System
- Purpose
- Examination on Efficacy of Retina Projection System
- Patients
- Low vision patients
- Methods
- Vision aids
- Retina Projection System
- Face-mounted video display as control
- Comparison of Reading Speeds with both vision aids
Read the detailed description
- Purpose
- Examination on efficacy of a new vision aid of Retina Projection System
- Patients
- Low vision patients
- Vision between 0.06 and 0.3
- no exclusion on kinds of ocular diseases
- Methods
- Vision aids
- Retina Projection System
- Face-mounted video display as control
- Computer-aided measurement of reading speeds of individual characters
- Comparison of reading Speeds with the two vision aids
- Conditions
- Vision, Low
- Keywords
- Low vision
- Medical subject headings
- Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading speeds with two different vision aids
Measured: Visits for measuring reading speeds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionNov 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision, LowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka City University
- Sponsor type
- University, hospital or other
- Collaborators
- Nihon University, Kurume University, Miyata Eye Hospital, Fukuoka Kinen Hospital, Kimura Eye and Internal Medicine Hospital
- Investigators
- Kunihiko Shiraki, MD, Study director, Dept. of Ophthalmology and Visual Sciences, Osaka City University, Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219427
- Sponsor's protocol ID
- OCUM2004681
- Other IDs
- OCUM2004681
- Status last verified
- May 2008
- First submitted
- 14 Sep 2005
- Last updated
- 22 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Trials of Retina Projection System
- ClinicalTrials.gov ID
- NCT00219427
- Acronym / sponsor ID
- OCUM2004681
- Conditions
- Vision, Low
- Keywords
- Low vision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Osaka City UniversityUniversity, hospital or other
- Collaborators
- Nihon University, Kurume University, Miyata Eye Hospital, Fukuoka Kinen Hospital, Kimura Eye and Internal Medicine Hospital
- Study start
- Jan 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Purpose
- Examination on Efficacy of Retina Projection System
- Patients
- Low vision patients
- Methods
- Vision aids
- Retina Projection System
- Face-mounted video display as control
- Comparison of Reading Speeds with both vision aids
Detailed description
- Purpose
- Examination on efficacy of a new vision aid of Retina Projection System
- Patients
- Low vision patients
- Vision between 0.06 and 0.3
- no exclusion on kinds of ocular diseases
- Methods
- Vision aids
- Retina Projection System
- Face-mounted video display as control
- Computer-aided measurement of reading speeds of individual characters
- Comparison of reading Speeds with the two vision aids
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (2 listed)
- low vision patients
- vision between 0.06 and 0.3
Key exclusion criteria (3 listed)
- light perception
- hand motion
- vision less than 0.06
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reading speeds with two different vision aids
Time frame: Visits for measuring reading speeds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2008.
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Beacon Sensors and Telerehabilitation to Assess and Improve Use of Devices (BeST-AID) for Low Vision
Low Vision, Low Vision Aids
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Effectiveness of a Multi-disciplinary Vision Rehabilitation Programme in Improving the Overall Quality of Life of Visually Impaired Adults
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Recruiting
Visual Remapping to Aid Reading With Field Loss
Age-related Macular Degeneration
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Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kunihiko Shiraki, MD study director
Dept. of Ophthalmology and Visual Sciences, Osaka City University, Graduate School of Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vision, Low, run by Osaka City University at 6 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading speeds with two different vision aids (time frame: Visits for measuring reading speeds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2008; AzTrials last refreshed its copy on 26 Oct 2026.