NCT01733550UnknownNot Applicable
ICare Self-tonometry - A Head-to-head Comparison to the Gold Standard Goldmann Tonometer
Universitaire Ziekenhuizen KU Leuven1 site in 1 country30 target enrollmentStarted: November 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Intra-ocular pressure with Home ICare and Goldmann Applanation Tonometer.
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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 Outcomes
- Patient Comfort(1 day hospitalisation)
Investigators
Study Sites (1)
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