ICare Self-tonometry - A Head-to-head Comparison to the Gold Standard Goldmann Tonometer

November 27, 2012 updated by: Universitaire Ziekenhuizen KU Leuven
The purpose of this study is to compare glaucoma patients' own I Care measurements by the standard Goldmann applanation tonometer intraocular pressure (IOP) measurements.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

not necessary

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZLeuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Glaucoma patients who are admitted to the hospital for repeated eye pressure measurements learn how to handle the home i care during their stay.

Description

Inclusion Criteria:

  • Ocular hypertension (OHT):with/without glaucoma drugs
  • Primary open angle glaucoma (POAG)- high pressure: Diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (IOP) >21 mmHg.
  • Primary open angle glaucoma, normal pressure: cfr high pressure but intraocular pressure ≤ 21 mmHg
  • Exfoliative Glaucoma (PEX): Diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (IOP) >21 mmHg, with exfoliation material in the anterior segment.
  • Pigmentary Glaucoma (PDG): Diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (IOP) >21 mmHg, with Krukenberg's spindle and/or pigment dispersed on the trabecular meshwork.

Exclusion Criteria:

  • Age <18 years
  • Other glaucoma types
  • Corneal pathology (edema, dystrophia, corneal transplantation, severe keratoconus, permanent contact lens wear, recurrent corneal erosion)
  • Severe arthritis (unable to handle home i care device)
  • Lack of comprehension
  • Intra ocular surgery and laser treatment during the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Glaucoma patients
Intraocular pressure is measured by Home iCare performed by the study nurse, by the patient it self and by Goldmann applanation tonometry.
Device: Home iCare (study nurse)
the intraocular pressure is measured by iCare performed by the study nurse
Device: goldmann applanation tonometry
the intraocular pressure is measured by goldmann applanation tonometry
Device: home iCare (by patient)
the intraocular pressure is measured by the iCare performed by the patient him self

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-ocular pressure with Home ICare and Goldmann Applanation Tonometer.
Time Frame: immediate comparison, no time frame required

Patients eye pressure measurement with both devices.

  1. Home ICare measurement by study nurse compared to Home ICare by patient compared to Goldmann ATO by study nurse (once for every patient)
  2. 4 times daily: measurement Goldmann ATO (by resident in ophthalmology) and home Icare (by patient)on same moment
immediate comparison, no time frame required

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Comfort
Time Frame: 1 day hospitalisation
The comfort of the patients will be checked with both methods (home iCare and goldmann applanation tonometry) and look if the patient has a preference for one of them. Pain and discomfort were scaled from 0 to 5 (0 = none,1-2 = slight, 3-4 = moderate, 5 = severe) for both tonometers, and patients were asked which tonometer they preferred.
1 day hospitalisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Ingeborg Stalmans, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ANTICIPATED)

April 1, 2013

Study Completion (ANTICIPATED)

April 1, 2013

Study Registration Dates

First Submitted

October 31, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (ESTIMATE)

November 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s54640

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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