Impact of Self-tonometry on Glaucoma Treatment Decision.

NCT04888156 | Completed

• 1 other identifier: iCare Home
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

glaucoma; self-tonometry; treatment; IOP peaks

Outcome Measures

Primary Outcomes (1)

• Clinician's choice of glaucoma treatment

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

  One month

Secondary Outcomes (1)

• Occurence of IOP peaks

  Three days of self-tonometry

Study Arms (2)

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; Other: Changed treatment

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; Other: Changed treatment

Interventions

Unchanged treatment OTHER

Treatment is the same pre- and post self-tonometry

GAT IOP below 15 mmHg; GAT IOP equal or above 15 mmHg

Changed treatment OTHER

Treatment is changed post self-tonometry

GAT IOP below 15 mmHg; GAT IOP equal or above 15 mmHg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• More than one measurement with iCare Home® tonometer below 5 mmHg
• Missing more than one daily measurement with iCare Home® tonometer

Sponsors & Collaborators

• St. Erik Eye Hospital: lead

Study Sites (1)

St Erik Eye Hospital

Stockholm, 11282, Sweden

Location

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Exfoliation Syndrome

Condition Hierarchy (Ancestors)

Eye Diseases; Iris Diseases; Uveal Diseases

Study Officials

• Enping Chen, MD PhD

  St. Erik Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Ph D

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 17, 2021
• Study Start: May 10, 2021
• Primary Completion: November 30, 2021
• Study Completion: February 1, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)