Evaluation of the Distortion Correction Data Collection (DCDC) App Software

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.

Study Overview

• Status: Completed
• Conditions: Age-related Macular Degeneration
• Intervention / Treatment: Other: DCDC App

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198-5540
      • University of Nebraska Medical Center, Truhlsen Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DCDC app; Subjects will evaluate the DCDC app	Other: DCDC App; The DCDC app is an experimental software that allows users to map their visual distortions on a tablet computer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Vikas Gulati, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 17, 2014
• First Submitted That Met QC Criteria: January 12, 2015
• First Posted (Estimated): January 13, 2015

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: 0625-14-FB