Macular DegenerationNCT01670643
Reading Performance With a Video Magnifier
An observational study of Macular Degeneration, run by Mary Lou Jackson at 1 site in United States.
Trial summary
The most common goal for patients with vision loss who present for vision rehabilitation is to be able to read. The video magnifier (a device which combines a video camera and a screen to view the print being magnified) is the device which most often allows low-vision individuals to read successfully for extended… Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Video camera magnifier
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Feb 2011
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy
Who may be able to join
- Central field loss and decreased visual acuity in the better seeing eye (<20/40 \& >20/400).
- New patient at MEEI Low Vision Rehabilitation Clinic
Who cannot join
- Dementia (Mini-Mental State Examination)
- Clinical depression (Geriatric Depression Scale)
- Patients who previously received vision rehabilitation
- Patients who have previously owned a desktop video magnifier
Trial locations and contacts
1 site in 1 country.
United States1 site
Vision Rehabilitation Clinic Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
About this study
Official title: The Effect of Video Camera Magnifier Use on Reading
The most common goal for patients with vision loss who present for vision rehabilitation is to be able to read. The video magnifier (a device which combines a video camera and a screen to view the print being magnified) is the device which most often allows low-vision individuals to read successfully for extended periods of time. Previous studies on the outcomes of vision rehabilitation have not identified which components of the vision rehabilitation are effective. The hypothesis of this project is that providing a video camera magnifier, with basic training in operating the device, will allow patients to enhance both objective reading ability and subjective report of reading competence.
Read the detailed description
Patients will be given a video magnifier at initial consultation or at the end of vision rehabilitation
- Conditions
- Macular Degeneration
- Being tested
- Video camera magnifier
- Keywords
- AMD, vision rehabilitation, video camera magnifier, IVI, DASS
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video camera magnifierBehavioural
Also called Optelec video magnifier
reading with video camera magnifier
| Study group | Role | What they receive |
|---|---|---|
| Video camera magnifier | Not described Receives: Behavioral: Video camera magnifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in objective reading performance
The subject undergoes testing to determine the change in reading performance on an objective scale.
Measured: baseline and one month
Secondary outcomes (1)
Change in subjective reading performance
The subject is asked to describe subjectively how they feel their ability to read has either improved or decreased since using the reader.
Measured: baseline and one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary Lou Jackson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mary Lou Jackson, Massachusetts Eye and Ear Infirmary
- Investigators
- Mary Lou Jackson, MD, Principal investigator, Vision Rehabilitation Center MEEI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670643
- Sponsor's protocol ID
- 09-11-116
- Other IDs
- 09-11-116
- Status last verified
- Mar 2017
- First submitted
- 6 Dec 2010
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video Camera Magnifier Use on Reading
- ClinicalTrials.gov ID
- NCT01670643
- Acronym / sponsor ID
- 09-11-116
- Conditions
- Macular Degeneration
- Keywords
- AMD, vision rehabilitation, video camera magnifier, IVI, DASS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mary Lou JacksonUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 22 Aug 2012 (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.
The most common goal for patients with vision loss who present for vision rehabilitation is to be able to read. The video magnifier (a device which combines a video camera and a screen to view the print being magnified) is the device which most often allows low-vision individuals to read successfully for extended periods of time. Previous studies on the outcomes of vision rehabilitation have not identified which components of the vision rehabilitation are effective. The hypothesis of this project is that providing a video camera magnifier, with basic training in operating the device, will allow patients to enhance both objective reading ability and subjective report of reading competence.
Detailed description
Patients will be given a video magnifier at initial consultation or at the end of vision rehabilitation
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video camera magnifier | – | Behavioral: Video camera magnifier |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy
Key inclusion criteria (2 listed)
- Central field loss and decreased visual acuity in the better seeing eye (<20/40 \& >20/400).
- New patient at MEEI Low Vision Rehabilitation Clinic
Key exclusion criteria (4 listed)
- Dementia (Mini-Mental State Examination)
- Clinical depression (Geriatric Depression Scale)
- Patients who previously received vision rehabilitation
- Patients who have previously owned a desktop video magnifier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video camera magnifierAlso: Optelec video magnifierreading with video camera magnifier | Behavioural | Video camera magnifier |
Primary outcome
Change in objective reading performance
Time frame: baseline and one month
The subject undergoes testing to determine the change in reading performance on an objective scale.
1 secondary outcome
Change in subjective reading performance
Time frame: baseline and one month
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 27 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Mary Lou Jackson, MD principal investigator
Vision Rehabilitation Center MEEI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Degeneration, run by Mary Lou Jackson at 1 site in United States.
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 4 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Change in objective reading performance (time frame: baseline and one month). 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 27 Mar 2017.