ICare Self-tonometry - A Head-to-head Comparison to the Gold Standard Goldmann Tonometer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01733550|
Recruitment Status : Unknown
Verified September 2012 by Universitaire Ziekenhuizen Leuven.
Recruitment status was: Not yet recruiting
First Posted : November 27, 2012
Last Update Posted : November 28, 2012
|Condition or disease||Intervention/treatment|
|Glaucoma||Device: Home iCare (study nurse) Device: goldmann applanation tonometry Device: home iCare (by patient)|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||ICare Self-tonometry - A Head-to-head Comparison to the Gold Standard Goldmann Tonometer|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||April 2013|
|Estimated Study Completion Date :||April 2013|
Intraocular pressure is measured by Home iCare performed by the study nurse, by the patient it self and by Goldmann applanation tonometry.
Device: Home iCare (study nurse)
the intraocular pressure is measured by iCare performed by the study nurseDevice: goldmann applanation tonometry
the intraocular pressure is measured by goldmann applanation tonometryDevice: home iCare (by patient)
the intraocular pressure is measured by the iCare performed by the patient him self
- 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.
- 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
- Patient Comfort [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733550
|Contact: Sien Boons, Optometristemail@example.com|
|Contact: Evelien Dewilde, Residentfirstname.lastname@example.org|
|UZLeuven||Not yet recruiting|
|Leuven, Belgium, 3000|
|Contact: Sien Boons, Optometrist +3216332361 email@example.com|
|Principal Investigator: Ingeborg Stalmans|
|Principal Investigator:||Ingeborg Stalmans||Universitaire Ziekenhuizen Leuven|