Impact of Self-tonometry on Glaucoma Treatment Decision.

Sponsor
St. Erik Eye Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04888156
Collaborator
(none)
133
1
8.8
15.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Unchanged treatment
  • Other: Changed 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 Design

Study Type:
Observational
Actual Enrollment :
133 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Impact of Self-tonometry With iCare Home ® on Glaucoma Treatment Decision.
Actual Study Start Date :
May 10, 2021
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Occurence of IOP peaks [Three days of self-tonometry]

    Occurence of IOP peaks measured by self-tonometry

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St Erik Eye Hospital Stockholm Sweden 11282

Sponsors and Collaborators

  • St. Erik Eye Hospital

Investigators

  • Principal Investigator: Enping Chen, MD PhD, St. Erik Eye Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Enping Chen, MD Ph D, St. Erik Eye Hospital
ClinicalTrials.gov Identifier:
NCT04888156
Other Study ID Numbers:
  • iCare Home
First Posted:
May 17, 2021
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Enping Chen, MD Ph D, St. Erik Eye Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022