Macular DegenerationNCT00926913
Investigating Optical and Neural Causes of Vision Loss
An observational study of Macular Degeneration, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
With the aging of the population, the prevalence of age-related macular degeneration (AMD) eye disease has resulted in a large number of people suffering from central vision loss. In fact, the most prevalent cause of blindness among veterans is AMD. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jul 2015
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal healthy subjects and patients diagnosed with age-related macular degeneration and central vision loss will participate in the study.
Who may be able to join
- Standard inclusion criteria are:
- qualification for entry into the study based on clinical evaluation,
- competence to understand and willingness to sign an informed consent form and participate in the study,
- pupils that dilate to 5 mm or more.
- The inclusion criteria for normal subjects will be:
- corrected visual acuities better than 20/30,
Show all 11Show fewer
- intraocular pressure less than 21 mm Hg,
- no family history of AMD,
- no history of ophthalmic surgery or neurologic disease,
- no history of diabetes, glaucoma, or a history of elevated intraocular pressure.
- The recruitment will ensure that approximately 40 subjects will fall into each of the three age groups, 50 to 60 years, 61 to 70 years, and 71 years and older. One eye of each subject will be selected at random to be included in the study.
Who cannot join
- Ocular opacities that preclude acquiring a clear fundus photograph or refractive errors greater than 4 diopters.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
About this study
With the aging of the population, the prevalence of age-related macular degeneration (AMD) eye disease has resulted in a large number of people suffering from central vision loss. In fact, the most prevalent cause of blindness among veterans is AMD. Since the number of elderly veterans is expected to double in the next 10 years, loss of vision due to AMD is also expected to proportionally and considerably escalate. People with impaired vision have difficulty with daily activities, such as, reading, driving, and recognizing faces. The goal of the research project is to provide information on factors that contribute to visual impairment. This knowledge is necessary for the development of innovative approaches that will optimize the benefit of vision rehabilitation techniques, aimed at improving vision, thus allowing our veterans to maintain function and productivity. The findings from the proposed research will benefit our veterans and all aging people.
Read the detailed description
Vision loss has become a major public health problem due to the growth and aging of the population. Age-related macular degeneration (AMD) is the most common cause of vision loss in people over 50 years of age. In the United States, over 10 million people have AMD and over 1.6 million people age 50 and older have late-stage advanced AMD. It is well established that AMD patients with central vision loss use preferred retinal loci (PRL) which are peripheral retinal areas adjacent to the fovea for performing daily activities, such as reading. However, even in healthy eyes, peripheral vision is limited due to reduced neural sampling density compared to the fovea. Additionally, the function of the peripheral retina can be further reduced in patients, owing to degenerative disease processes. These neural substrate losses are coupled with losses in the quality of the optical image on the retina. Optical imperfections increase with age and off-axis viewing, compared to viewing along the optical axis of the eye. The combination of these factors plays a significant role in reducing visual performance of patients with eccentric fixation. The long term goal of the project is to improve the visual performance of veterans with central vision loss by development of innovative approaches that will optimize the benefit of vision rehabilitation techniques. In the current proposal, optical and neural losses will be assessed in AMD patients with central vision loss using novel techniques. Increased optical losses due to age and viewing off the optical axis of the eye will be established with wavefront analysis technology. Increased neural losses due to retinal dysfunction at PRL will be determined based on measurement of visual acuity with blurred stimuli. Improvement in reading speed will be evaluated, conditional on neural losses at PRL and/or the stability of PRL, after compensating for optical losses with our adaptive optics system. The findings will provide knowledge of PRL function and stability that is beneficial for improving the outcome of available vision rehabilitation methods that train patients to better use their PRLs. Also, customized correction of optical imperfections of the eye for effectively improving visual performance can be developed as an approach for better vision rehabilitation of patients. Optimizing vision rehabilitation of our veterans will allow them to maintain function and productivity.
- Conditions
- Macular Degeneration
- Keywords
- Macular Degeneration
- Medical subject headings
- Macular Degeneration
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 |
|---|---|---|
| Group 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular aberrations
Measured: One time only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startDec 2014
- Primary completionMar 2015
- Study completionJul 2015 (estimated)
Why it stopped: Project has ended
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mahnaz Shahidi, PhD, Principal investigator, Jesse Brown VA Medical Center, Chicago, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926913
- Sponsor's protocol ID
- C7002-R
- Status last verified
- Apr 2015
- First submitted
- 22 Jun 2009
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Optical and Neural Causes of Vision Loss
- ClinicalTrials.gov ID
- NCT00926913
- Acronym / sponsor ID
- C7002-R
- Conditions
- Macular Degeneration
- Keywords
- Macular Degeneration
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Project has ended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (estimated)
- First posted
- 24 Jun 2009 (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.
With the aging of the population, the prevalence of age-related macular degeneration (AMD) eye disease has resulted in a large number of people suffering from central vision loss. In fact, the most prevalent cause of blindness among veterans is AMD. Since the number of elderly veterans is expected to double in the next 10 years, loss of vision due to AMD is also expected to proportionally and considerably escalate. People with impaired vision have difficulty with daily activities, such as, reading, driving, and recognizing faces. The goal of the research project is to provide information on factors that contribute to visual impairment. This knowledge is necessary for the development of innovative approaches that will optimize the benefit of vision rehabilitation techniques, aimed at improving vision, thus allowing our veterans to maintain function and productivity. The findings from the proposed research will benefit our veterans and all aging people.
Detailed description
Vision loss has become a major public health problem due to the growth and aging of the population. Age-related macular degeneration (AMD) is the most common cause of vision loss in people over 50 years of age. In the United States, over 10 million people have AMD and over 1.6 million people age 50 and older have late-stage advanced AMD. It is well established that AMD patients with central vision loss use preferred retinal loci (PRL) which are peripheral retinal areas adjacent to the fovea for performing daily activities, such as reading. However, even in healthy eyes, peripheral vision is limited due to reduced neural sampling density compared to the fovea. Additionally, the function of the peripheral retina can be further reduced in patients, owing to degenerative disease processes. These neural substrate losses are coupled with losses in the quality of the optical image on the retina. Optical imperfections increase with age and off-axis viewing, compared to viewing along the optical axis of the eye. The combination of these factors plays a significant role in reducing visual performance of patients with eccentric fixation. The long term goal of the project is to improve the visual performance of veterans with central vision loss by development of innovative approaches that will optimize the benefit of vision rehabilitation techniques. In the current proposal, optical and neural losses will be assessed in AMD patients with central vision loss using novel techniques. Increased optical losses due to age and viewing off the optical axis of the eye will be established with wavefront analysis technology. Increased neural losses due to retinal dysfunction at PRL will be determined based on measurement of visual acuity with blurred stimuli. Improvement in reading speed will be evaluated, conditional on neural losses at PRL and/or the stability of PRL, after compensating for optical losses with our adaptive optics system. The findings will provide knowledge of PRL function and stability that is beneficial for improving the outcome of available vision rehabilitation methods that train patients to better use their PRLs. Also, customized correction of optical imperfections of the eye for effectively improving visual performance can be developed as an approach for better vision rehabilitation of patients. Optimizing vision rehabilitation of our veterans will allow them to maintain function and productivity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal healthy subjects and patients diagnosed with age-related macular degeneration and central vision loss will participate in the study.
Key inclusion criteria (11 listed)
- qualification for entry into the study based on clinical evaluation,
- competence to understand and willingness to sign an informed consent form and participate in the study,
- pupils that dilate to 5 mm or more.
- corrected visual acuities better than 20/30,
- intraocular pressure less than 21 mm Hg,
Key exclusion criteria (1 listed)
- Ocular opacities that preclude acquiring a clear fundus photograph or refractive errors greater than 4 diopters.
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
Ocular aberrations
Time frame: One time only
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
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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.
Mahnaz Shahidi, PhD principal investigator
Jesse Brown VA Medical Center, Chicago, IL
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 US Department of Veterans Affairs 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 11 inclusion and 1 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: withdrawn, as of the sponsor's last update on 6 Apr 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Ocular aberrations (time frame: One time only). 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 6 Apr 2015.