iCare® Home vs Goldmann Applanation Tonometry

NCT04911387 | Completed

• 1 other identifier: iCare Home vs GAT
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Self-tonometry with iCare Home is regularly performed at Sankt Erik's Eye Hospital since a few years back. The purpose of this study was to show that the eye pressure measurements made with iCare® Home by patients / relatives do not vary more than those made with the standard method, Goldman applanation tonometry (GAT), by different healthcare professionals. This will hopefully confirm the usefulness of self-tonometry.

Conditions

Glaucoma; Open Angle Glaucoma; Ocular Hypertension; Pseudo Exfoliation Syndrome

Keywords

intraocular pressure; GAT; rebound tonometry; self-tonometry; iCare® Home

Outcome Measures

Primary Outcomes (2)

• Correlation between iCare® Home inter-user measurements

  iCare® Home measurements made by participants (patients and volunteers) will be compared to iCare® Home measurements made by trainers' using the same device on the same occasion

  12 months

• Correlation between GAT measurements made by different healthcare personnel

  GAT measurements made by iCare® Home trainers will be compared to GAT measurements made by other available healthcare personnel using a different device on the same occasion

  12 months

Secondary Outcomes (1)

• Agreement between iCare® Home tonometry and GAT

  12 months

Interventions

Intraocular pressure measurments DEVICE

Intraocular pressure measurements with iCare Home by participants (patients, volunteers) and healthcare staff as well as intraocular pressure measurements with GAT by participants different healthcare staff.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients who are referred to the clinic to perform a Eye pressure curve with iCare® Home are offered to participate in the study. The patient him-/herself or someone accompanying him/her may perform the measurements. Volunteer without an eye history to participate.

You may qualify if:

• primary open angle glaucoma (POAG)
• pseudo-exfoliation glaucoma (PEX)
• ocular hypertension (OHT)
• no eye disease,

You may not qualify if:

• inability to perform measurements due to limited hand or arm mobility (eg rheumatism, tremor)
• measurements outside the iCare® Home manufacturer's recommendations.

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 Ph D

  St. Erik Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 3, 2021
• Study Start: April 1, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: June 3, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)