Age-Related Macular DegenerationNCT02422160
Vision Outcomes Using Quantitative Optical Coherence Tomography Evaluation in Age Related Macular Degeneration
An observational study of Age-Related Macular Degeneration, run by Stanford University at 1 site in United States.
Trial summary
The investigators have developed an image analysis method that can predict the likelihood that a patient with age related macular degeneration (AMD) will progress within 1 year, based on computerized analysis of optical coherence tomography (OCT) images that are routinely acquired in clinical practice on each patient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-exudative age-related macular degneration
Who may be able to join
- Non-exudative age-related macular degeneration
Who cannot join
- Exudative age-related macular degeneration
Trial locations and contacts
1 site in 1 country.
United States1 site
Byers Eye Institute at Stanford
Palo Alto, California, 94303
About this study
The investigators have developed an image analysis method that can predict the likelihood that a patient with age related macular degeneration (AMD) will progress within 1 year, based on computerized analysis of optical coherence tomography (OCT) images that are routinely acquired in clinical practice on each patient visit to the ophthalmologist. The investigators' goal is to evaluate whether this method will improve the ability to detect AMD earlier and improve visual outcomes in AMD patients by assigning patient risk categories and having patients come back for follow up based on those categories.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- No interventions are planned
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions are plannedOther
No interventions are planned
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Measured: Two Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theodore Leng, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422160
- Sponsor's protocol ID
- 33624
- Status last verified
- May 2022
- First submitted
- 16 Apr 2015
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vision Outcomes Using Quantitative Optical Coherence Tomography Evaluation in Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02422160
- Acronym / sponsor ID
- 33624
- Conditions
- Age-Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 21 Apr 2015 (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 investigators have developed an image analysis method that can predict the likelihood that a patient with age related macular degeneration (AMD) will progress within 1 year, based on computerized analysis of optical coherence tomography (OCT) images that are routinely acquired in clinical practice on each patient visit to the ophthalmologist. The investigators' goal is to evaluate whether this method will improve the ability to detect AMD earlier and improve visual outcomes in AMD patients by assigning patient risk categories and having patients come back for follow up based on those categories.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-exudative age-related macular degneration
Key inclusion criteria (1 listed)
- Non-exudative age-related macular degeneration
Key exclusion criteria (1 listed)
- Exudative age-related macular degeneration
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 |
|---|---|---|
| No interventions are plannedNo interventions are planned | Other | – |
Primary outcome
Visual Acuity
Time frame: Two Years
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 17 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stanford University 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 17 May 2022. 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?
Visual Acuity (time frame: Two Years). 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 17 May 2022.