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

NCT02337647 | Completed

• 1 other identifier: 0625-14-FB
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

DCDC app

OTHER

Subjects will evaluate the DCDC app

Other: DCDC App

Interventions

DCDC App OTHER

The DCDC app is an experimental software that allows users to map their visual distortions on a tablet computer.

DCDC app

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center, Truhlsen Eye Institute

Omaha, Nebraska, 68198-5540, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Vikas Gulati, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: January 13, 2015
• Study Start: December 29, 2014
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 6, 2023

Record last verified: 2023-08

Locations

US (1)