Home Tonometry With the I-care Tonometer for Glaucoma
|ClinicalTrials.gov Identifier: NCT02656836|
Recruitment Status : Completed
First Posted : January 15, 2016
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment|
|Glaucoma||Other: Home tonometry, diagnostic study|
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.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Home Tonometry for Monitoring Glaucoma:a Pilot Study of the Icare Home Tonometer|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
- Other: Home tonometry, diagnostic study
Evaluating intraocular pressureOther Name: I-care tonometer
- 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.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656836
|Centre for Experimental Medicine QUB|
|Belfast, Co.Antrim, United Kingdom, BT12 6BA|
|Principal Investigator:||Augusto Azuara-Blanco||Queen's University, Belfast|