Impact of Self-tonometry on Glaucoma Treatment Decision.

March 1, 2022 updated by: Enping Chen, St. Erik Eye Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 11282
        • St Erik Eye Hospital

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All glaucoma patients who obtained an IOP curve using an iCare Home® self-tonometer between January 2018 and December 2020 and who fulfill all the inclusion criteria and none of the exclusion criteria.

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GAT IOP below 15 mmHg
Glaucoma patients with an IOP measured with GAT below 15 mmHg prior performance of self-tonometry with iCare Home
Other: Unchanged treatment
Treatment is the same pre- and post self-tonometry
Other: Changed treatment
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
Other: Unchanged treatment
Treatment is the same pre- and post self-tonometry
Other: Changed treatment
Treatment is changed post self-tonometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician's choice of glaucoma treatment
Time Frame: One month
Type of treatment received by patient after performance of self-tonometry with iCare Home
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of IOP peaks
Time Frame: Three days of self-tonometry
Occurence of IOP peaks measured by self-tonometry
Three days of self-tonometry

Collaborators and Investigators

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

Sponsor

St. Erik Eye 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 (ACTUAL)

May 10, 2021

Primary Completion (ACTUAL)

November 30, 2021

Study Completion (ACTUAL)

February 1, 2022

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (ACTUAL)

May 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iCare Home

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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