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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01733550
Enrollment
30
Registered
2012-11-27
Start date
2012-11-30
Completion date
2013-04-30
Last updated
2012-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

Intraocular Pressure, Tonometry, Ocular, iCare

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.

Detailed description

not necessary

Interventions

DEVICEHome iCare (study nurse)

the intraocular pressure is measured by iCare performed by the study nurse

DEVICEgoldmann applanation tonometry

the intraocular pressure is measured by goldmann applanation tonometry

DEVICEhome iCare (by patient)

the intraocular pressure is measured by the iCare performed by the patient him self

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Intra-ocular pressure with Home ICare and Goldmann Applanation Tonometer.immediate comparison, no time frame requiredPatients 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

MeasureTime frameDescription
Patient Comfort1 day hospitalisationThe 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.

Countries

Belgium

Contacts

Primary ContactSien Boons, Optometrist
sien.boons@uzleuven.be+32-16-33-23-61
Backup ContactEvelien Dewilde, Resident
evelien.dewilde@uzleuven.be+32-16-33-23-61

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026