Age-related Macular DegenerationNCT02337647
Evaluation of the Distortion Correction Data Collection (DCDC) App Software
A study testing DCDC App in people with Age-related Macular Degeneration, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of the research study is to evaluate how well the Distortion Correction Data Collection (DCDC) App works. The DCDC App is an experimental software application that is being developed at the University of Nebraska Omaha. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- DCDC App
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2014to 1 Jun 2016
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55 years of age or greater
- Diagnosed with age-related macular degeneration (AMD).
- Best corrected visual acuity (BCVA) of (20/40 to 20/200 Snellen equivalent).
- Visual distortion is present in at least one eye, as determined by Amsler grid evaluation.
- Have had the following imaging tests completed within the past three months as part of standard of care: optical coherence tomography (OCT), scanning laser ophthalmoscopy (SLO), and Fluorescein angiography (FA).
- Capable of understanding the requirements of the study, willing to follow study instructions, able to provide written informed consent to participate, and willing to comply with all study requirements.
- Women who are post-menopausal or not otherwise of child-bearing potential -
Who cannot join
- Visual field loss from diseases other than AMD.
- Visual distortions from the following conditions other than AMD: epiretinal membrane, diabetic macular edema, central retinal vein occlusion (CRVO) with edema, and cystoid macular edema.
- A medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease ability to follow study instructions.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, Truhlsen Eye Institute
Omaha, Nebraska, 68198-5540
About this study
Official title: Evaluation of the Distortion Correction Data Collection (DCDC) App Software to Repair Visual Distortions for Low Vision Age-related Macular Degeneration, and the Correlation of the Distortions With Clinical Examination
The purpose of the research study is to evaluate how well the Distortion Correction Data Collection (DCDC) App works. The DCDC App is an experimental software application that is being developed at the University of Nebraska Omaha. The DCDC app will map and draw the visual distortions of patients with Age-related Macular degeneration.
Read the detailed description
This research study is a phase 1 clinical trial to evaluate the efficacy of the Distortion Correction Data Collection (DCDC) App on a computer tablet system. There are two objectives in this study. The primary objective is to evaluate the functionality of the visual distortion app on the tablet computer. Patients will draw their distortions on the tablet screen, and the app will record and correct the distortions.The second objective is to create a distortion data repository (DDR) that contains retinal maps, data pertaining to the anatomical and functional aspects of patients retinas and the distortions. This DDR will be used to correlate retinal health to distortions.The correlation will be key in improving the correction software of the app. Long term, the app will be used to create a diagnostic tool and improve image processing in retinal prosthesis systems.
Participating subjects must be at least 55 years of age or older with age-related macular degeneration (AMD). After consent, a chart review will be performed. At the baseline visit, subjects will have an electroretinogram (ERG). At the single study visit, to be scheduled within 2 weeks of the baseline visit, subjects will use the DCDC app on a tablet computer to trace their visual distortions on an Amsler grid. Up to 5 subjects who meet the inclusion/exclusion criteria will be enrolled. The duration of the study is a 2 hour baseline visit and a 1 hour study visit, all within 2 weeks.
- Conditions
- Age-related Macular Degeneration
- Being tested
- DCDC App
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCDC AppOther
The DCDC app is an experimental software that allows users to map their visual distortions on a tablet computer.
| Study group | Role | What they receive |
|---|---|---|
| DCDC app | Other | Subjects will evaluate the DCDC app Receives: Other: DCDC App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionality of the Distortion Correction Data Collection App (DCDC), as measured by successful usage of the app by subjects.
Subjects will use the app to trace visual distortions. The app will correct these distortions, subjects will give feedback on these corrections. Test will be repeated two times.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study start29 Dec 2014
- Primary completion1 Mar 2016
- Study completion1 Jun 2016
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vikas Gulati, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337647
- Sponsor's protocol ID
- 0625-14-FB
- Status last verified
- Aug 2023
- First submitted
- 17 Dec 2014
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Distortion Correction Data Collection (DCDC) App Software to Repair Visual Distortions for Low Vision Age-related Macular Degeneration, and the Correlation of the Distortions With Clinical Examination
- ClinicalTrials.gov ID
- NCT02337647
- Acronym / sponsor ID
- 0625-14-FB
- Conditions
- Age-related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 29 Dec 2014 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 13 Jan 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 purpose of the research study is to evaluate how well the Distortion Correction Data Collection (DCDC) App works. The DCDC App is an experimental software application that is being developed at the University of Nebraska Omaha. The DCDC app will map and draw the visual distortions of patients with Age-related Macular degeneration.
Detailed description
This research study is a phase 1 clinical trial to evaluate the efficacy of the Distortion Correction Data Collection (DCDC) App on a computer tablet system. There are two objectives in this study. The primary objective is to evaluate the functionality of the visual distortion app on the tablet computer. Patients will draw their distortions on the tablet screen, and the app will record and correct the distortions.The second objective is to create a distortion data repository (DDR) that contains retinal maps, data pertaining to the anatomical and functional aspects of patients retinas and the distortions. This DDR will be used to correlate retinal health to distortions.The correlation will be key in improving the correction software of the app. Long term, the app will be used to create a diagnostic tool and improve image processing in retinal prosthesis systems.
Participating subjects must be at least 55 years of age or older with age-related macular degeneration (AMD). After consent, a chart review will be performed. At the baseline visit, subjects will have an electroretinogram (ERG). At the single study visit, to be scheduled within 2 weeks of the baseline visit, subjects will use the DCDC app on a tablet computer to trace their visual distortions on an Amsler grid. Up to 5 subjects who meet the inclusion/exclusion criteria will be enrolled. The duration of the study is a 2 hour baseline visit and a 1 hour study visit, all within 2 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCDC app | Other | Other: DCDC AppSubjects will evaluate the DCDC app |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 55 years of age or greater
- Diagnosed with age-related macular degeneration (AMD).
- Best corrected visual acuity (BCVA) of (20/40 to 20/200 Snellen equivalent).
- Visual distortion is present in at least one eye, as determined by Amsler grid evaluation.
- Have had the following imaging tests completed within the past three months as part of standard of care: optical coherence tomography (OCT), scanning laser ophthalmoscopy (SLO), and Fluorescein angiography (FA).
Key exclusion criteria (3 listed)
- Visual field loss from diseases other than AMD.
- Visual distortions from the following conditions other than AMD: epiretinal membrane, diabetic macular edema, central retinal vein occlusion (CRVO) with edema, and cystoid macular edema.
- A medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease ability to follow study instructions.
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 |
|---|---|---|
| DCDC AppThe DCDC app is an experimental software that allows users to map their visual distortions on a tablet computer. | Other | DCDC app |
Primary outcome
Functionality of the Distortion Correction Data Collection App (DCDC), as measured by successful usage of the app by subjects.
Time frame: 3 months
Subjects will use the app to trace visual distortions. The app will correct these distortions, subjects will give feedback on these corrections. Test will be repeated two times.
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 Sep 2023.
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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.
Vikas Gulati, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DCDC App in people with Age-related Macular Degeneration, run by University of Nebraska 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 7 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 6 Sep 2023. 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?
Functionality of the Distortion Correction Data Collection App (DCDC), as measured by successful usage of the app by subjects. (time frame: 3 months). 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 Sep 2023.