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OpenTrials
Completed

NCT Number: NCT04888156

Impact of Self-tonometry 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Erik Eye Hospital

Stockholm, 11282, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unchanged treatment

Other

Treatment is the same pre- and post self-tonometry

Changed treatment

Other

Treatment is changed post self-tonometry

Primary outcomes

  1. Clinician's choice of glaucoma treatment

    Time frame: One month

    Type of treatment received by patient after performance of self-tonometry with iCare Home

Secondary outcomes

  1. Occurence of IOP peaks

    Time frame: Three days of self-tonometry

    Occurence of IOP peaks measured by self-tonometry

Sponsors and collaborators

Lead sponsor

St. Erik Eye Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 17, 2021
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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