Augmented Reality Mobile Application for Glaucoma Education in the South Bronx

July 21, 2022 updated by: Dr. Stephen Lau, Bronx-Lebanon Hospital Center Health Care System
A team at the National Healthcare Group Eye Institute in Singapore have developed an augmented reality mobile phone application, EyeCU, to simulate glaucoma progression and enhance understanding about the disease and its course. It is a bilingual (English/Spanish) application that is free-to-download on the Android and Apple app store. As eye care physicians in the South Bronx, the investigators are hopeful that the findings in this study can be extrapolated to our patients in the South Bronx, where poor health literacy, non-adherence to glaucoma medication and poor follow-up remains a large barrier. The investigators hope that by offering the simulation in both English and Spanish, the investigators will not only be able to improve our patients' understanding of glaucoma, but also improve glaucoma treatment adherence and assess our patient population's responsiveness to augmented reality as an educational platform.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Experimental design: Pilot cohort study

Data collection: Patient characteristics such as age, sex, ethnicity, preferred language, zip code, employment status, highest educational attainment, current topical eye medications, Past Ocular History, Past Medical History

Recruitment for participation in the study will be performed during glaucoma clinic registration Consent will be conducted by a member of the research team who is not directly involved in the participant's clinical care Pre-intervention glaucoma knowledge questionnaire (NEHEP glaucoma knowledge questionnaire) will be given to participants, to be completed on dedicated clinic tablet device.

Post-intervention glaucoma knowledge questionnaire (NEHEP glaucoma knowledge questionnaire) will be given to participants, to be completed on dedicated clinic tablet device.

Rate of missed glaucoma follow-up appointments before and 6 months after application use will be collected from the electronic medical record.

Rate of medication adherence before and 6 months after application use will be collected from the electronic medical record.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10457
        • BronxCare Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Patients with a clinical diagnosis of glaucoma on medical therapy for at least 4 months

Exclusion Criteria:

  • Patients with optic neuropathies unrelated to glaucoma
  • Patients with VA 20/100 or worse in both eyes
  • Visual defects involving fixation in both eyes
  • Patients with symptoms impairing ability to operate a smartphone during visit including diplopia, motor difficulties, cognitive impairment, illiteracy
  • Patients who are unable to read or understand English or Spanish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EyeCU App
Augmented reality mobile application called "EyeCU" which simulates glaucoma progression and enhances understanding about the disease and its course. It is a bilingual (English/Spanish) application that is free-to-download on the Android and Apple app store. It will be delivered on a hospital owned tablet device and patients will be instructed to complete two sections, taking approximately 10 minutes.
Other: EyeCU Mobile Application
Augmented reality glaucoma education mobile phone application

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Questionnaire Scores
Time Frame: From date of intervention to date of post-intervention NEHEP glaucoma knowledge test, assessed up to 2 months
Scores of pre- and post-intervention NEHEP glaucoma knowledge questionnaires will be compared
From date of intervention to date of post-intervention NEHEP glaucoma knowledge test, assessed up to 2 months
Change in Follow Up Adherence
Time Frame: Before and 6 months after intervention
Attendance rate at glaucoma follow-ups will be collected from electronic medical record
Before and 6 months after intervention
Change in Medication Adherence
Time Frame: Before and 6 months after intervention
Self-reported adherence to glaucoma medications will be collected from electronic medical record
Before and 6 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bronx-Lebanon Hospital Center Health Care System

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
EyeCU Group
VISRE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11141902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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