Home eye pressure checks with a smartphone for people with glaucoma

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with newly diagnosed primary open-angle glaucoma and fairly good vision. It compares home eye pressure checks plus phone messages with phone messages alone.

Age

18 years or older

Sex

All sexes can join

Disease stage

Newly diagnosed primary open-angle glaucoma (POAG)

Earlier treatment

No previous eye surgery or corneal refractive surgery, except uncomplicated cataract removal

Main reasons for not taking part

• Eye pressure above 35 mmHg
• Dry eye syndrome
• Only one eye with functional vision
• Pathological myopia
• Diabetic retinopathy or maculopathy

The registry criteria, word for word

What the trial wants to find out

The goal of this clinical trial is to conduct a study randomizing glaucoma patients to home intra-ocular pressure (IOP) telemonitoring combined with Smart phone-based intervention (Management Paradigm I) or Smart phone-based intervention alone (Management Paradigm II), with the objectives to compare (1) Goldmann applanation tonometry (GAT) intra-ocular pressure (IOP) measurements over the entire study period (primary outcome measure) and (2) the rates of Retinal nerve fiber layer (RNFL) thinning (secondary outcome measure) between the two Management Paradigms. We hypothesize that glaucoma patients randomized to Management Paradigm I will (1) attain lower levels of intra-ocular pressure (IOP), and (2) a slower rate of Retinal nerve fiber layer (RNFL) and ganglion cell inner plexiform layer (GCIPL) thinning compared with those randomized to Management Paradigm II because of having a more precise assessment of intra-ocular pressure (IOP) to guide intra-ocular pressure (IOP)- lowering therapy would be feasible in Management Paradigm I.

The 2 groups in the trial

• Management Paradigm I: Home IOP telemonitoring with smart phone-based interventionExisting treatment, for comparison

  Before treatment initiation, patients perform 4 weeks of baseline home IOP measurements, then continue to obtain at least six IOP measurements per week (two readings in the early morning, and one each at mid-day and evening on two days per week) and upload readings via the iCare CLINIC cloud platform. Investigators review home IOP data every 4 weeks and adjust topical IOP-lowering therapy according to a predefined algorithm whenever fewer than 75% of home readings are below the target IOP based on disease severity. Every 4 weeks, patients receive smartphone text messages indicating whether the home-based target IOP has been achieved and reminding them about eye-drop adherence; patients report missed doses by text, and a nurse calls patients who do not reply or who submit fewer than 20 home IOP readings in 4 weeks.

  Treatment: Home IOP telemonitoring with smart phone-based intervention

• Management paradigm II: Standard care and smart phone-based interventionExisting treatment, for comparison

  Topical IOP-lowering therapy is escalated according to the same predefined stepwise protocol used in Management Paradigm I when target IOP is not reached. No home IOP telemonitoring is used; treatment decisions rely on clinic-measured IOP and structural/functional assessments. Every 4 weeks, patients receive smartphone text messages indicating whether the target pressure has been attained based on the latest clinic Goldmann measurement and reminding them about eye-drop adherence; patients report missed doses by text, and clinic staff follow up by phone as needed.

  Treatment: Standard care and smart phone-based intervention