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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01733550
First received: October 31, 2012
Last updated: November 27, 2012
Last verified: September 2012

October 31, 2012
November 27, 2012
November 2012
April 2013   (final data collection date for primary outcome measure)
Intra-ocular pressure with Home ICare and Goldmann Applanation Tonometer. [ Time Frame: immediate comparison, no time frame required ] [ Designated as safety issue: No ]

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
Comparison [ Time Frame: immediate comparison, no time frame required ] [ Designated as safety issue: No ]
Comparison intra-ocular pressure measured by Home ICare with Goldmann Applanation Tonometer and look for agreement
Complete list of historical versions of study NCT01733550 on ClinicalTrials.gov Archive Site
Patient Comfort [ Time Frame: 1 day hospitalisation ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
ICare Self-tonometry - A Head-to-head Comparison to the Gold Standard Goldmann Tonometer
ICare Self-tonometry - A Head-to-head Comparison to the Gold Standard Goldmann Tonometer

The purpose of this study is to compare glaucoma patients' own I Care measurements by the standard Goldmann applanation tonometer intraocular pressure (IOP) measurements.

not necessary

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Glaucoma patients who are admitted to the hospital for repeated eye pressure measurements learn how to handle the home i care during their stay.

Glaucoma
  • Device: Home iCare (study nurse)
    the intraocular pressure is measured by iCare performed by the study nurse
  • Device: goldmann applanation tonometry
    the intraocular pressure is measured by goldmann applanation tonometry
  • Device: home iCare (by patient)
    the intraocular pressure is measured by the iCare performed by the patient him self
Glaucoma patients
Intraocular pressure is measured by Home iCare performed by the study nurse, by the patient it self and by Goldmann applanation tonometry.
Interventions:
  • Device: Home iCare (study nurse)
  • Device: goldmann applanation tonometry
  • Device: home iCare (by patient)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Sien Boons, Optometrist +32-16-33-23-61 sien.boons@uzleuven.be
Contact: Evelien Dewilde, Resident +32-16-33-23-61 evelien.dewilde@uzleuven.be
Belgium
 
NCT01733550
s54640
Yes
Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Principal Investigator: Ingeborg Stalmans Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP