Impact of Self-tonometry on Glaucoma Treatment Decision.

Completed

• Conditions: Glaucoma, Open-Angle; Glaucoma Capsulare; OHT - Ocular Hypertension; Glaucoma
• Interventions: Other: Unchanged treatment; Other: Changed treatment

• Registration Number: NCT04888156
• Lead Sponsor: St. Erik Eye Hospital

Brief Summary

Self-tonometry with iCare Home is performed by one hundred patients annually at Sankt Erik's Eye Hospital. The investigators want to evaluate the impact that self-tonometry results have on the clinician's choice of glaucoma treatment. The investigators also want to evaluate how often pressure peaks occur outside the clinic's opening hours.

Detailed Description

Since a few years back, self-tonometry has been available in glaucoma care. Self-tonometry allows patients to measure their eye pressure themselves using a portable tonometer. Sankt Erik's Eye Hospital was the first healthcare provider in Sweden to use this new technology. The investigators have previously conducted studies that have shown good agreement between the measurements made by patients and the gold standard method, e.g. Goldman applanation tonometry (GAT) (Chen, Querat et al. 2016, Querat and Chen 2017). About one hundred patients perform pressure curves with self-tonometry annually.

As the method is used regularly, the investigators want to evaluate the impact of self-tonometry results on the clinician's choice of glaucoma treatment. The investigators also want to evaluate how often pressure peaks occur outside the clinic's opening hours and how much they differ from GAT.

Study Timeline

• Study Start: 2021-05-10
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-17
• Primary Completion: 2021-11-30
• Study Completion: 2022-02-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

• Age ≥ 18 years
• Diagnosed with POAG (primary open-angle glaucoma), PEX (pseudo-exfoliation glaucoma) or OHT (ocular hypertension)
• Difference between patients' and staff's iCare Home® measurements less than 5 mmHg at Baseline
• Difference between Goldman Applanation tonometry (GAT) and patient's highest iCare Home® measurements less than 7 mmHg at baseline
• Monitoring over at least two days

Exclusion Criteria

• More than one measurement with iCare Home® tonometer below 5 mmHg
• Missing more than one daily measurement with iCare Home® tonometer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GAT IOP below 15 mmHg	Unchanged treatment	Glaucoma patients with an IOP measured with GAT below 15 mmHg prior performance of self-tonometry with iCare Home
GAT IOP equal or above 15 mmHg	Changed treatment	Glaucoma patients with an IOP measured with GAT equal or above 15 mmHg prior performance of self-tonometry with iCare Home
GAT IOP below 15 mmHg	Changed treatment	Glaucoma patients with an IOP measured with GAT below 15 mmHg prior performance of self-tonometry with iCare Home
GAT IOP equal or above 15 mmHg	Unchanged treatment	Glaucoma patients with an IOP measured with GAT equal or above 15 mmHg prior performance of self-tonometry with iCare Home

Primary Outcome Measures

Name	Time	Method
Clinician's choice of glaucoma treatment	One month	Type of treatment received by patient after performance of self-tonometry with iCare Home

Secondary Outcome Measures

Name	Time	Method
Occurence of IOP peaks	Three days of self-tonometry	Occurence of IOP peaks measured by self-tonometry

Trial Locations

Locations (1)

St Erik Eye Hospital; 🇸🇪 Stockholm, Sweden