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

• Conditions: Glaucoma
• Interventions: Device: Home iCare (study nurse); Device: goldmann applanation tonometry; Device: home iCare (by patient)

• Registration Number: NCT01733550
• Lead Sponsor: Universitaire Ziekenhuizen KU 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.

Detailed Description

not necessary

Study Timeline

• Status Verified: 2012-09
• Study First Submitted: 2012-10-31
• Study Start: 2012-11
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-27
• Last Update Submitted: 2012-11-27
• Last Update Posted: 2012-11-28
• Primary Completion: 2013-04
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glaucoma patients	Home iCare (study nurse)	Intraocular pressure is measured by Home iCare performed by the study nurse, by the patient it self and by Goldmann applanation tonometry.
Glaucoma patients	goldmann applanation tonometry	Intraocular pressure is measured by Home iCare performed by the study nurse, by the patient it self and by Goldmann applanation tonometry.
Glaucoma patients	home iCare (by patient)	Intraocular pressure is measured by Home iCare performed by the study nurse, by the patient it self and by Goldmann applanation tonometry.

Primary Outcome Measures

Name	Time	Method
Intra-ocular pressure with Home ICare and Goldmann Applanation Tonometer.	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

Name	Time	Method
Patient Comfort	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.

Trial Locations

Locations (1)

UZLeuven; 🇧🇪 Leuven, Belgium