Impact of Self-tonometry on Glaucoma Treatment Decision.

NCT ID: NCT04888156

Last Updated: 2022-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-10

Study Completion Date

2022-02-01

Brief Summary

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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

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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.

Conditions

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Glaucoma Glaucoma, Open-Angle OHT - Ocular Hypertension Glaucoma Capsulare

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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GAT IOP below 15 mmHg

Glaucoma patients with an IOP measured with GAT below 15 mmHg prior performance of self-tonometry with iCare Home

Unchanged treatment

Intervention Type OTHER

Treatment is the same pre- and post self-tonometry

Changed treatment

Intervention Type OTHER

Treatment is changed post self-tonometry

GAT IOP equal or above 15 mmHg

Glaucoma patients with an IOP measured with GAT equal or above 15 mmHg prior performance of self-tonometry with iCare Home

Unchanged treatment

Intervention Type OTHER

Treatment is the same pre- and post self-tonometry

Changed treatment

Intervention Type OTHER

Treatment is changed post self-tonometry

Interventions

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Unchanged treatment

Treatment is the same pre- and post self-tonometry

Intervention Type OTHER

Changed treatment

Treatment is changed post self-tonometry

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Erik Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Enping Chen

MD Ph D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enping Chen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

St. Erik Eye Hospital

Locations

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St Erik Eye Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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iCare Home

Identifier Type: -

Identifier Source: org_study_id

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