Impact of Self-tonometry on Glaucoma Treatment Decision.

Glaucoma Clinical Trial

Official title:

Impact of Self-tonometry With iCare Home ® on Glaucoma Treatment Decision.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04888156
• Other study ID #: iCare Home
• Status: Completed
• Start date: May 10, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: March 2022
• Source: St. Erik Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: February 1, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Exfoliation Syndrome
• Glaucoma
• Glaucoma Capsulare
• Glaucoma, Open-Angle
• Ocular Hypertension
• OHT - Ocular Hypertension

Intervention

Other:
• Unchanged treatment
Treatment is the same pre- and post self-tonometry
• Changed treatment
Treatment is changed post self-tonometry

Locations

Country	Name	City	State
Sweden	St Erik Eye Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
St. Erik Eye Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician's choice of glaucoma treatment	Type of treatment received by patient after performance of self-tonometry with iCare Home	One month
Secondary	Occurence of IOP peaks	Occurence of IOP peaks measured by self-tonometry	Three days of self-tonometry