Trial Outcomes & Findings for Home Tonometry With the I-care Tonometer for Glaucoma (NCT NCT02656836)

Last Updated: 2020-02-05

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

Two weeks

Results posted on

2020-02-05

Participant Flow

Could not recruit target number of participants within the time frame

Participant milestones

Participant milestones
Measure	Home Tonometry Group No comparator
Overall Study STARTED	9
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Home Tonometry With the I-care Tonometer for Glaucoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Home Tonometry Group n=6 Participants No comparator
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Two weeks

Outcome measures

Outcome measures
Measure	Home Tonometry Group n=6 Participants
Intraocular Pressure	-1.85 mmHg Standard Deviation 3.95

SECONDARY outcome

Timeframe: Two weeks

Proportion of patients willing to use the tonometer but are unable to. Patient feedback reported via questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One month

Any adverse event or complication associated with the use of the device. Expected side effects will be corneal erosion, and ocular irritation.

Outcome measures

Outcome data not reported

Adverse Events

Home Tonometry Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Augusto Azuara-Blanco

Queen's University Belfast

Phone: 2890976350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place