Age-related Macular DegenerationNCT03166202
Age-Related Macular Degeneration, Scotopic Dysfunction, and Driving Performance in a Simulator
An observational study of Age-related Macular Degeneration, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Previous work collectively suggests that rod-mediated dark adaptation (RMDA) is a promising candidate as a functional endpoint measure for evaluating interventions to slow early progression of age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Age-related Macular Degeneration
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 5 Mar 2019
- 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 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults living in the community who have current driver's license who have age-related macular degeneration
Who may be able to join
- age-related macular degeneration in one or both eyes, ability to follow simple instructions, licensed to drive a vehicle, can read and speak English
Who cannot join
- diabetes, retinal or optic nerve conditions other than age-related macular degeneration, neurological conditions that impair vision
Trial locations and contacts
1 site in 1 country.
United States1 site
Callahan Eye Hospital, UAB Dept of Ophthalmolog & Visual Sciences
Birmingham, Alabama, 35294-0009
About this study
Previous work collectively suggests that rod-mediated dark adaptation (RMDA) is a promising candidate as a functional endpoint measure for evaluating interventions to slow early progression of age-related macular degeneration (AMD). However, there is no agreement among the clinical, research and regulatory communities as to what constitutes a clinically (practically) significant slowing in RMDA. Treatments for AMD are often not considered efficacious if they do not result in a criterion level of improvement in vision. But how much change in the rate of dark adaptation constitutes a clinically significant change? Until this issue is resolved, progress in developing clinical trials on early AMD are at a standstill since there is no functional endpoint to be used in the trial. One approach to establishing clinical significance is to examine how RMDA relates to the performance of an everyday visual task under low luminance conditions, such as night driving or reading. However, such data are not yet available. The purpose of this project is to examine the relationship between RMDA and night-time driving and reading under poor illumination. This information will guide the development of a definition of a clinically significant difference in RMDA that can be used in designing clinical trials on early AMD.
Read the detailed description
The specific aims of this study are as follows:
Aim 1: To examine the association between RMDA as assessed by the rod intercept time and self reported driving difficulty and experiences during night time driving.
Aim 2: To examine the association between RMDA as assessed by rod intercept time and reading performance as assessed by the MNREAD test administered under a low light level. Reading performance will be defined in terms of maximum reading speed, critical print size (i.e., the smallest print size that supports maximum reading speed), reading acuity (i.e., the smallest print size that can be just read) and the reading accessibility index (i.e., an individual's access to text over the range of print sizes found in everyday life).
- Conditions
- Age-related Macular Degeneration
- Keywords
- age-related macular degeneration
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
rod intercept time
rate of rod-mediated dark adaptation
Measured: measured once (1 day)
Secondary outcomes (1)
severity of age-related macular degeneration
defined by grading of color fundus photos
Measured: measured once (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start1 Sep 2018
- Primary completion5 Mar 2019
- Study completion5 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Owsley, University of Alabama at Birmingham
- Investigators
- Cynthia Owsley, PhD, Principal investigator, University of Alabama at BirminghamMiYoung Kwon, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166202
- Sponsor's protocol ID
- 228382017
- Status last verified
- Jun 2019
- First submitted
- 23 May 2017
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Once study is completed and published in the peer review literature, we will arrange for a data sharing process with other researchers
Publications
Owsley C, McGwin G Jr, Clark ME, Jackson GR, Callahan MA, Kline LB, Witherspoon CD, Curcio CA. Delayed Rod-Mediated Dark Adaptation Is a Functional Biomarker for Incident Early Age-Related Macular Degeneration. Ophthalmology. 2016 Feb;123(2):344-351. doi: 10.1016/j.ophtha.2015.09.041. Epub 2015 Oct 30.
PubMed 26522707
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Related Macular Degeneration, Scotopic Dysfunction, and Driving Performance in a Simulator
- ClinicalTrials.gov ID
- NCT03166202
- Acronym / sponsor ID
- 228382017
- Conditions
- Age-related Macular Degeneration
- Keywords
- age-related macular degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 5 Mar 2019 (actual)
- First posted
- 25 May 2017 (actual)
- 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.
Previous work collectively suggests that rod-mediated dark adaptation (RMDA) is a promising candidate as a functional endpoint measure for evaluating interventions to slow early progression of age-related macular degeneration (AMD). However, there is no agreement among the clinical, research and regulatory communities as to what constitutes a clinically (practically) significant slowing in RMDA. Treatments for AMD are often not considered efficacious if they do not result in a criterion level of improvement in vision. But how much change in the rate of dark adaptation constitutes a clinically significant change? Until this issue is resolved, progress in developing clinical trials on early AMD are at a standstill since there is no functional endpoint to be used in the trial. One approach to establishing clinical significance is to examine how RMDA relates to the performance of an everyday visual task under low luminance conditions, such as night driving or reading. However, such data are not yet available. The purpose of this project is to examine the relationship between RMDA and night-time driving and reading under poor illumination. This information will guide the development of a definition of a clinically significant difference in RMDA that can be used in designing clinical trials on early AMD.
Detailed description
The specific aims of this study are as follows:
Aim 1: To examine the association between RMDA as assessed by the rod intercept time and self reported driving difficulty and experiences during night time driving.
Aim 2: To examine the association between RMDA as assessed by rod intercept time and reading performance as assessed by the MNREAD test administered under a low light level. Reading performance will be defined in terms of maximum reading speed, critical print size (i.e., the smallest print size that supports maximum reading speed), reading acuity (i.e., the smallest print size that can be just read) and the reading accessibility index (i.e., an individual's access to text over the range of print sizes found in everyday life).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults living in the community who have current driver's license who have age-related macular degeneration
Key inclusion criteria (1 listed)
- age-related macular degeneration in one or both eyes, ability to follow simple instructions, licensed to drive a vehicle, can read and speak English
Key exclusion criteria (1 listed)
- diabetes, retinal or optic nerve conditions other than age-related macular degeneration, neurological conditions that impair vision
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
rod intercept time
Time frame: measured once (1 day)
rate of rod-mediated dark adaptation
1 secondary outcome
severity of age-related macular degeneration
Time frame: measured once (1 day)
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 6 Jun 2019.
- Background: PubMed 26522707Owsley C, McGwin G Jr, Clark ME, Jackson GR, Callahan MA, Kline LB, Witherspoon CD, Curcio CA. Delayed Rod-Mediated Dark Adaptation Is a Functional Biomarker for Incident Early Age-Related Macular Degeneration. Ophthalmology. 2016 Feb;123(2):344-351. doi: 10.1016/j.ophtha.2015.09.041. Epub 2015 Oct 30.
- Individual participant dataSharing planned: Undecided. Once study is completed and published in the peer review literature, we will arrange for a data sharing process with other researchers
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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.
Cynthia Owsley, PhD principal investigator
University of Alabama at Birmingham
MiYoung Kwon, PhD principal investigator
University of Alabama at Birmingham
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 Age-related Macular Degeneration, run by University of Alabama at Birmingham 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 1 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: finished, as of the sponsor's last update on 6 Jun 2019. 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?
rod intercept time (time frame: measured once (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03166202, which also lists 1 linked publication.
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 Jun 2019.