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

NCT01733550 | Unknown DMC

• 1 other identifier: s54640
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

Intraocular Pressure; Tonometry, Ocular; iCare

Outcome Measures

Primary Outcomes (1)

• Intra-ocular pressure with Home ICare and Goldmann Applanation Tonometer.

  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

  immediate comparison, no time frame required

Secondary Outcomes (1)

• Patient Comfort

  1 day hospitalisation

Study Arms (1)

Glaucoma patients

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); Device: goldmann applanation tonometry; Device: home iCare (by patient)

Interventions

Home iCare (study nurse) DEVICE

the intraocular pressure is measured by iCare performed by the study nurse

Glaucoma patients

goldmann applanation tonometry DEVICE

the intraocular pressure is measured by goldmann applanation tonometry

Glaucoma patients

home iCare (by patient) DEVICE

the intraocular pressure is measured by the iCare performed by the patient him self

Glaucoma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Ingeborg Stalmans

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sien Boons, Optometrist

CONTACT

+32-16-33-23-61; sien.boons@uzleuven.be

Evelien Dewilde, Resident

CONTACT

+32-16-33-23-61; evelien.dewilde@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 27, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 28, 2012

Record last verified: 2012-09

Locations

BE (1)