NCT07480577

Brief Summary

This study evaluates whether a personalized mobile reminder program improves treatment adherence and clinical outcomes in adults with primary open-angle glaucoma (POAG) using topical antiglaucoma eye drops. Poor adherence to long-term eye-drop therapy is common in glaucoma care and may contribute to inadequate intraocular pressure (IOP) control and disease progression. Participants are randomized to either (1) a digital adherence intervention or (2) standard outpatient follow-up. The intervention consists of daily interactive SMS/WhatsApp medication reminders plus weekly brief educational messages for 3 months. The primary outcome is change in medication adherence measured by the Morisky Medication Adherence Scale-8 (MMAS-8) at month 3. Secondary outcomes include change in IOP, eye-drop instillation technique, and treatment satisfaction. Exploratory analyses assess the relationship between adherence level and OCT-based retinal nerve fiber layer (RNFL) progression metrics. The goal is to determine whether a low-cost, scalable mobile strategy can improve short-term glaucoma management in routine practice.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 14, 2026

Last Update Submit

March 14, 2026

Conditions

Keywords

Primary Open-Angle GlaucomaMedication AdherenceMobile ReminderSMS ReminderWhatsApp ReminderMMAS-8

Outcome Measures

Primary Outcomes (1)

  • Change in Medication Adherence

    Difference in Morisky Medication Adherence Scale-8 (MMAS-8) total score from baseline to month 3, and between-group comparison of mean change. Higher scores indicate better adherence.

    Baseline and Month 3

Secondary Outcomes (1)

  • Change in Intraocular Pressure (IOP)

    Baseline and Month 3

Other Outcomes (1)

  • Association Between Adherence Level and OCT-Derived RNFL Progression Metrics

    Retrospective OCT data up to Month 3 assessment

Study Arms (2)

Digital Reminder Intervention

EXPERIMENTAL

Participants receive a personalized mobile adherence program in addition to standard glaucoma care, including daily interactive SMS/WhatsApp medication reminders and weekly brief educational messages for 3 months.

Behavioral: Digital Reminder Intervention

Standard Care

NO INTERVENTION

Participants receive routine outpatient glaucoma follow-up and prescribed topical antiglaucoma treatment without digital reminders.

Interventions

A behavioral adherence support intervention consisting of daily interactive SMS/WhatsApp reminders for eye-drop use and weekly educational reinforcement messages over 3 months.

Digital Reminder Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 to 75 years. Diagnosis of primary open-angle glaucoma (POAG) in at least one eye. Currently treated with at least one topical antiglaucoma medication. Able to read and understand study procedures and provide written informed consent.
  • Has regular access to a mobile phone capable of receiving SMS or WhatsApp messages.
  • Willing to comply with follow-up visits and study procedures for 3 month

You may not qualify if:

  • Secondary glaucoma (e.g., neovascular, uveitic, steroid-induced) or angle-closure glaucoma.
  • Ocular surgery or laser procedure within the previous 3 months, or planned ocular surgery during study follow-up.
  • Advanced ocular comorbidity likely to affect IOP assessment or adherence evaluation (e.g., severe corneal disease, active ocular infection/inflammation).
  • Cognitive impairment, severe psychiatric disease, or communication barriers that prevent reliable participation.
  • Inability to use or access mobile messaging tools required for the intervention.
  • Participation in another interventional clinical study that may interfere with outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma, Open-AngleMedication Adherence

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label behavioral intervention trial. Participants and treating clinicians are aware of assignment due to the nature of the mobile reminder intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomized in a 1:1 ratio to either a personalized mobile reminder intervention (daily interactive SMS/WhatsApp reminders plus weekly educational messages) or standard outpatient follow-up for 3 months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yenikent State Hospital, Head of Ophthalmology

Study Record Dates

First Submitted

March 14, 2026

First Posted

March 18, 2026

Study Start

April 1, 2026

Primary Completion

July 1, 2026

Study Completion

August 1, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03