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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01733550
Other study ID # s54640
Secondary ID
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


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
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