NCT04421859

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

2.5 years

First QC Date

May 29, 2020

Last Update Submit

July 21, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Questionnaire Scores

    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

    Attendance rate at glaucoma follow-ups will be collected from electronic medical record

    Before and 6 months after intervention

  • Change in Medication Adherence

    Self-reported adherence to glaucoma medications will be collected from electronic medical record

    Before and 6 months after intervention

Study Arms (1)

EyeCU App

EXPERIMENTAL

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

Interventions

Augmented reality glaucoma education mobile phone application

EyeCU App

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BronxCare Health System

The Bronx, New York, 10457, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmology Resident

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 9, 2020

Study Start

January 1, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

July 25, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations