Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04911387
Other study ID # iCare Home vs GAT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date October 31, 2020

Study information

Verified date May 2021
Source St. Erik Eye Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Since a few years back, self-tonometry with iCare® Home has been available in glaucoma care. Sankt Erik's Eye Hospital was first in Sweden to use the new technology. Several studies have shown good agreement between measurements made by patients or healthcare professionals with iCare® Home and Goldman applanation tonometry (GAT). However, some researchers raise critical voices about the reliability of iCare® Home measurements because they can differ from GAT. GAT is considered the gold standard method of tonometry to which all other instruments are compared. But like all other methods, GAT has some limitations. At the clinic, the eye pressure is usually measured with GAT by different staff (ophthalmological nurses, opticians or doctors) from visit to visit. This can sometimes lead to pressure variations that may affect the follow-up of glaucoma patients. This raises the question of whether the difference between GAT and iCare® Home is statistically and clinically significant. 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 GAT by different healthcare professionals. This will hopefully confirm the usefulness of self-tonometry.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date October 31, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - primary open angle glaucoma (POAG) - pseudo-exfoliation glaucoma (PEX) - ocular hypertension (OHT) - no eye disease, Exclusion Criteria: - inability to perform measurements due to limited hand or arm mobility (eg rheumatism, tremor) - measurements outside the iCare® Home manufacturer's recommendations.

Study Design


Intervention

Device:
Intraocular pressure measurments
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.

Locations

Country Name City State
Sweden St Erik Eye Hospital Stockholm

Sponsors (1)

Lead Sponsor Collaborator
St. Erik Eye Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Agreement between iCare® Home tonometry and GAT Agreement, repeatability and reliability of measurements made with iCare® Home tonometry and GAT will be assessed using Bland Altman analysis, ANOVA and interclass correlation coefficient (ICC). 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT06000865 - Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE N/A
Recruiting NCT06278597 - Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device N/A
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03274024 - The Asia Primary Tube Versus Trab (TVT) Study N/A
Completed NCT04552964 - Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma N/A
Recruiting NCT01957267 - Functional and Structural Imaging for Glaucoma
Active, not recruiting NCT04624698 - iStent Inject New Enrollment Post-Approval Study N/A
Completed NCT04020705 - The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma N/A
Completed NCT03150160 - Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma Phase 4
Not yet recruiting NCT05581498 - Glaucoma Exercise as Medicine Study (GEMS). N/A
Recruiting NCT02921568 - Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes N/A
Active, not recruiting NCT02901730 - Clinical Study of LPI With Different Laser Wavelengths N/A
Completed NCT02955849 - A Trial of China Laser and Surgery Study Glaucoma in Rural China Early Phase 1
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Recruiting NCT02554214 - Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device N/A
Active, not recruiting NCT02390284 - Stop Retinal Ganglion Cell Dysfunction Study Phase 3
Completed NCT02520674 - Glaucoma Screening With Smartphone Ophthalmology N/A
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT02653963 - Triamcinolone for Ahmed Glaucoma Valve N/A
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A