An observational study in Glaucoma, sponsored by Queen's University, Belfast. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Queen's University, Belfast · Observational
The overall objective of the study is to scope the self-management for self-monitoring glaucoma using home tonometry.
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 20 is below the median of 103 across 454 observational studies indexed under Glaucoma.
Browse Glaucoma studies →Queen's University, Belfast is the lead sponsor of 113 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with glaucoma attending clinic
Exclusion Criteria:
Evaluating intraocular pressure
Also known as: I-care tonometer
Intraocular Pressure
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.
Time frame: Two weeks
Proportion of Patients Able and Willing to Use the Tonometer
Proportion of patients willing to use the tonometer but are unable to. Patient feedback reported via questionnaire
Time frame: Two weeks
Proportion of Patients With an Adverse Event
Any adverse event or complication associated with the use of the device. Expected side effects will be corneal erosion, and ocular irritation.
Time frame: One month
Could not recruit target number of participants within the time frame
| Milestone | Home Tonometry Group |
|---|---|
| Started | 9 |
| Completed | 6 |
| Not completed | 3 |
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.
| mmHg | Home Tonometry Group |
|---|---|
| Intraocular Pressure | -1.85 ± 3.95 |
Proportion of patients willing to use the tonometer but are unable to. Patient feedback reported via questionnaire
Results for this outcome have not been posted.
Any adverse event or complication associated with the use of the device. Expected side effects will be corneal erosion, and ocular irritation.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Home Tonometry Group | — | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Home Tonometry Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 6 |
| Sex: Female, Male(Participants) | Home Tonometry Group |
|---|---|
| Female | 2 |
| Male | 4 |
| Race (NIH/OMB)(Participants) | Home Tonometry Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Home Tonometry Group |
|---|---|
| United Kingdom | 6 |
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Queen's University, Belfast