Clinical trial NCT02337647: Evaluation of the Distortion Correction Data Collection (DCDC) App Software
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Macular Degeneration
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 5
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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 -

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Functionality of the Distortion Correction Data Collection App (DCDC), as measured by successful usage of the app by subjects.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center, Truhlsen Eye Institute
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Vikas Gulati, MD
role: PRINCIPAL_INVESTIGATOR
References: