Glaucoma, Open-Angle [C11.525.381.407]
Conditions
Keywords
Glaucoma, Open angle glaucoma, ocular hypertension, compliance
Brief summary
The purpose of this study is to evaluate the usability of a medication management support system for glaucoma patients self-administering eye drops named iDropper. The iDropper system is a home-based ocular medication management system that reminds, instructs, dispenses, and records eye drop medication usage. The iDropper system will be evaluated among a cohort of glaucoma subjects self-administering eye drops for 4-weeks.
Detailed description
Glaucoma is a leading cause of vision loss in the United States, impacting the lives of \ 4 million people. Left untreated or inadequately managed, it causes blindness -- the second ranking cause of blindness in the world as well as the leader among African Americans. Estimates project 79.6 million glaucoma diagnoses worldwide by 2020; of these, 74% will have open-angle glaucoma (OAG), which occurs virtually without symptoms. The explanation for such strikingly high disease prevalence and blindness rates is partially due to the asymptomatic nature of glaucoma. However, deficient adherence to glaucoma ocular hypotensive drops is a significant and escalating health care problem. Glaucoma eye drops are often the first therapeutic choice and very effective at controlling intraocular pressure (IOP) to prevent eye damage. However, glaucoma is a chronic condition and daily dosing regimens for medications can be complex and difficult to manage with impaired vision. Consequently, adherence and persistence to glaucoma eye drop regimens over time becomes quite poor. Overwhelming research brings the unwelcome conclusion that long term persistence with glaucoma medication is 33-39% at one year and positively contributes to blindness. Currently, no mechanism exists for supporting and monitoring glaucoma eye drop compliance. The purpose of this study is to evaluate the usability of a medication management support system for glaucoma patients self-administering eye drops named iDropper. The iDropper system is a home-based ocular medication management system that reminds, instructs, dispenses, and records eye drop medication usage. The iDropper system will be evaluated among a cohort of glaucoma subjects self-administering eye drops for 4-weeks. At study conclusion usability and satisfaction assessments will be performed to evaluate iDropper system performance.
Interventions
DEVICEOpen angle glaucoma - iDropper device
The iDropper system is an eye drop dispensing device and medication monitor designed to optimize adherence behaviors for glaucoma patients.
Sponsors
National Eye Institute (NEI)
Care Team Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* At least 21 years of age; * Physician diagnosis of: open angle glaucoma, angle-closure glaucoma, glaucoma suspect, or ocular hypertension * Responsible for self-administration of eye drops. * No surgery within the prior 3 months; * Able to speak and read English;
Exclusion criteria
* Having any concurrent medical or psychiatric condition that, in the investigator's opinion, may preclude participation in this study; or * Cognitive or visual impairment that would interfere with completing a self-administered questionnaire.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability questionnaire | 4 weeks after trial start | Written questionnaire assessing usability of the iDropper system by participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction questionnaire | 4 weeks after study start | Questionnaire assessing participant satisfaction with features of the iDropper system. |
Countries
United States
Outcome results
None listed