Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Home Tonometry With the I-care Tonometer for Glaucoma

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: NCT02656836
Recruitment Status : Unknown
Verified January 2016 by Professor Augusto Azuara-Blanco, Queen's University, Belfast.
Recruitment status was:  Recruiting
First Posted : January 15, 2016
Last Update Posted : January 18, 2016
Sponsor:
Collaborator:
Belfast Health and Social Care Trust
Information provided by (Responsible Party):
Professor Augusto Azuara-Blanco, Queen's University, Belfast

Brief Summary:
The overall objective of the study is to scope the self-management for self-monitoring glaucoma using home tonometry.

Condition or disease Intervention/treatment
Glaucoma Other: Home tonometry, diagnostic study

Detailed Description:

Monitoring of glaucoma requires frequent evaluation of IOP and disease severity, typically with visual field tests. When a patient is diagnosed with glaucoma an optimum level of IOP (or target IOP) is determined based on patient's characteristics, such as severity of disease and life expectancy. In current models of care patients have their IOP measured at the clinic at different intervals. If the IOP is noted to be high, or above the patient's target, additional treatment is recommended. Accurate and frequent IOP measurements at different points in time are thus imperative.

Tonometry is usually conducted by clinicians in an eye clinic. Some tonometers (e.g., Icare) have the potential to be used by the individual for home monitoring of IOP for patients with suspected glaucoma/glaucoma. Self-monitoring of IOP via home tonometry will allow patients to undergo IOP measurements at different points in time (e.g., early morning and night-time, and it can help determine diurnal changes and spikes).

The overall objective of the current study is to conduct a feasibility pilot study on the home tonometer (Icare), acquiring initial experience with the Icare tonometer. For this purpose investigators will train up to 20 individuals on how to use the device. Investigators will ask them to record in a diary their IOP twice a day for a period of 2 weeks. Investigators will then compare IOP outcomes with the measurement taken at the clinic. Patients and clinicians will be masked to the IOP data.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Home Tonometry for Monitoring Glaucoma:a Pilot Study of the Icare Home Tonometer
Study Start Date : November 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma


Intervention Details:
  • Other: Home tonometry, diagnostic study
    Evaluating intraocular pressure
    Other Name: I-care tonometer


Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: Two weeks ]
    Intraocular pressure in mmHg units, obtained by tonometers. The investigators will determine agreement of intraocular pressure (IOP) measured using the home tonometer (patient) compared with IOP measured in the clinic.


Secondary Outcome Measures :
  1. Proportion of patients able and willing to use the tonometer [ Time Frame: Two weeks ]
    Proportion of patients willing to use the tonometer but are unable to. Patient feedback reported via questionnaire

  2. Proportion of patients with an adverse event [ Time Frame: One month ]
    Any adverse event or complication associated with the use of the device. Expected side effects will be corneal erosion, and ocular irritation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with glaucoma attending clinic
Criteria

Inclusion Criteria:

  1. Attending the glaucoma clinic for monitoring (for glaucoma or ocular hypertension)
  2. Aged 18 years or over
  3. Patient deemed able to monitor their IOP at home (by themselves or a helper)

Exclusion Criteria:

  1. Not receiving IOP monitoring (for glaucoma or ocular hypertension)
  2. Aged <18 years
  3. Patients deemed unable to monitor their IOP at home (and do not have someone who can help them) e.g., apparent physical or cognitive impairments that will not allow for the use of a home tonometer
  4. Had surgery for their glaucoma (glaucoma surgery only; other surgeries included e.g., cataract surgery)
  5. Patient has preexisting corneal disease

Information from the National Library of Medicine

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): NCT02656836


Contacts
Layout table for location contacts
Contact: Augusto Azuara-Blanco +44 (0)28 90632507 a.azuara-blanco@qub.ac.uk

Locations
Layout table for location information
United Kingdom
Centre for Experimental Medicine QUB Recruiting
Belfast, Co.Antrim, United Kingdom, BT12 6BA
Contact: Augusto Azuara-Blanco, PhD       a.azuara-blanco@qub.ac.uk   
Principal Investigator: Augusto Azuara-Blanco, PhD         
Sponsors and Collaborators
Queen's University, Belfast
Belfast Health and Social Care Trust
Investigators
Layout table for investigator information
Principal Investigator: Augusto Azuara-Blanco Queen's University, Belfast

Layout table for additonal information
Responsible Party: Professor Augusto Azuara-Blanco, Professor, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT02656836     History of Changes
Other Study ID Numbers: REC 15/EM/0217
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Ocular Hypertension
Eye Diseases