Personalized Mobile Reminders for Medication Adherence and Intraocular Pressure Control in Primary Open-Angle Glaucoma (M-GLAUCO)

March 14, 2026 updated by: Ali Altan Ertan Boz, Sakarya Yenikent State Hospital

Effectiveness of a Personalized Mobile Reminder System on Medication Adherence and Intraocular Pressure Control in Primary Open-Angle Glaucoma: A Prospective, Parallel-Group, Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary open-angle glaucoma (POAG) is a chronic optic neuropathy in which sustained reduction of intraocular pressure (IOP) remains the main modifiable treatment target. In real-world care, nonadherence and incorrect eye-drop technique are frequent and can reduce treatment effectiveness. Digital reminder systems may improve adherence behavior; however, prospective randomized evidence in routine glaucoma clinics is still limited.

This is a single-center, prospective, parallel-group, randomized controlled trial designed to assess the effectiveness of a personalized mobile reminder intervention in adults with POAG receiving topical antiglaucoma treatment. A total of 84 participants are allocated 1:1 to intervention or standard care.

Intervention arm participants receive:

Daily interactive medication reminders (SMS/WhatsApp) Weekly short educational messages focused on glaucoma, medication use, and practical adherence support Control arm participants continue standard outpatient follow-up without the digital reminder package.

Follow-up duration is 3 months. The primary endpoint is change in MMAS-8 score from baseline to month 3. Secondary endpoints are change in IOP, change in correct eye-drop instillation technique, and treatment satisfaction. Exploratory analyses evaluate whether higher adherence is associated with more favorable OCT-derived RNFL slope patterns (global and quadrant-based estimates from retrospective imaging data).

Planned statistical comparisons include between-group analyses using independent-samples t tests and adjusted analyses using ANCOVA. Analyses are performed on a complete-case basis for the 3-month follow-up period. Because of single-center design, modest sample size, and short follow-up, structural OCT findings are considered exploratory and hypothesis-generating.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital Reminder Intervention
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
A behavioral adherence support intervention consisting of daily interactive SMS/WhatsApp reminders for eye-drop use and weekly educational reinforcement messages over 3 months.
No Intervention: Standard Care
Participants receive routine outpatient glaucoma follow-up and prescribed topical antiglaucoma treatment without digital reminders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Medication Adherence
Time Frame: Baseline and Month 3
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Intraocular Pressure (IOP)
Time Frame: Baseline and Month 3
Change in mean IOP (mmHg) from baseline to month 3 and adjusted between-group difference.
Baseline and Month 3

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association Between Adherence Level and OCT-Derived RNFL Progression Metrics
Time Frame: Retrospective OCT data up to Month 3 assessment
Exploratory association between adherence strata and retrospective OCT-based global and quadrant retinal nerve fiber layer (RNFL) slope estimates.
Retrospective OCT data up to Month 3 assessment

Collaborators and Investigators

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

Sponsor

Sakarya Yenikent State Hospital

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 (Estimated)

April 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 14, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 14, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026/1 (Atatürk University Clinical Research Ethics Committee)

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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