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

Study Overview
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Brief Summary
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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
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not necessary

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

Conditions
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Glaucoma

Intervention / Treatment
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* Device: Home iCare (study nurse)
* Device: goldmann applanation tonometry
* Device: home iCare (by patient)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glaucoma patients<br>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)<br>* the intraocular pressure is measured by iCare performed by the study nurse<br>Device: goldmann applanation tonometry<br>* the intraocular pressure is measured by goldmann applanation tonometry<br>Device: home iCare (by patient)<br>* the intraocular pressure is measured by the iCare performed by the patient him self<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-ocular pressure with Home ICare and Goldmann Applanation Tonometer. | Patients eye pressure measurement with both devices. Home ICare measurement by study nurse compared to Home ICare by patient compared to Goldmann ATO by study nurse (once for every patient) 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular Pressure, Tonometry, Ocular, iCare