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

• Conditions: Glaucoma

• 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

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