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

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ClinicalTrials.gov Identifier: NCT01733550
Recruitment Status : Unknown
Verified September 2012 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Not yet recruiting
First Posted : November 27, 2012
Last Update Posted : November 28, 2012
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
The purpose of this study is to compare glaucoma patients' own I Care measurements by the standard Goldmann applanation tonometer intraocular pressure (IOP) measurements.

Condition or disease Intervention/treatment
Glaucoma Device: Home iCare (study nurse) Device: goldmann applanation tonometry Device: home iCare (by patient)

Detailed Description:
not necessary

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ICare Self-tonometry - A Head-to-head Comparison to the Gold Standard Goldmann Tonometer
Study Start Date : November 2012
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733550


Contacts
Contact: Sien Boons, Optometrist +32-16-33-23-61 sien.boons@uzleuven.be
Contact: Evelien Dewilde, Resident +32-16-33-23-61 evelien.dewilde@uzleuven.be

Locations
Belgium
UZLeuven Not yet recruiting
Leuven, Belgium, 3000
Contact: Sien Boons, Optometrist    +3216332361    sien.boons@uzleuven.be   
Principal Investigator: Ingeborg Stalmans         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Ingeborg Stalmans Universitaire Ziekenhuizen Leuven

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01733550     History of Changes
Other Study ID Numbers: s54640
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: September 2012

Keywords provided by Universitaire Ziekenhuizen Leuven:
Intraocular Pressure
Tonometry, Ocular
iCare