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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01733550
• Other study ID #: s54640
• Status: Not yet recruiting
• Phase: N/A
• First received: October 31, 2012
• Last updated: November 27, 2012
• Start date: November 2012
• Est. completion date: April 2013

Study information

• Verified date: September 2012
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Sien Boons, Optometrist
• Phone: +32-16-33-23-61
• Email: sien.boons[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

not necessary

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Home iCare (study nurse)
the intraocular pressure is measured by iCare performed by the study nurse
• goldmann applanation tonometry
the intraocular pressure is measured by goldmann applanation tonometry
• home iCare (by patient)
the intraocular pressure is measured by the iCare performed by the patient him self

Locations

Country	Name	City	State
Belgium	UZLeuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No