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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04421859
Other study ID # 11141902
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date June 30, 2022

Study information

Verified date July 2022
Source Bronx-Lebanon Hospital Center Health Care System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
EyeCU Mobile Application
Augmented reality glaucoma education mobile phone application

Locations

Country Name City State
United States BronxCare Health System Bronx New York

Sponsors (3)

Lead Sponsor Collaborator
Bronx-Lebanon Hospital Center Health Care System EyeCU Group, VISRE

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Change in Follow Up Adherence Attendance rate at glaucoma follow-ups will be collected from electronic medical record Before and 6 months after intervention
Primary Change in Medication Adherence Self-reported adherence to glaucoma medications will be collected from electronic medical record Before and 6 months after intervention
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