Trial Outcomes & Findings for Reliability and Reproducibility of the Eye Check Tonometer (NCT NCT04639947)

NCT ID: NCT04639947

Last Updated: 2024-10-08

Results Overview

Compare EyeCheck intraocular pressure (IOP) measurements comparable to those of traditional tonometers (Goldmann and tonopen)

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2024-10-08

Participant Flow

Each study participant was enrolled into both arms. Therefore 22 subjects were enrolled and had testing in each arm.

Unit of analysis: eyes

Participant milestones

Measure	EyeCheck and Traditional Tonometer (Goldmann and Tonopen) EyeCheck pressures will be measured with contact lens in place EyeCheck: EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes. Pressures will be measured with both Goldmann and Tonopen (both traditional tonometers to take the intraocular pressure (IOP) measurements of the eye). Traditional Tonometer (Goldmann and Tonopen): Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck.
Overall Study STARTED	22 22
Overall Study COMPLETED	21 21
Overall Study NOT COMPLETED	1 1

Reasons for withdrawal

Measure

EyeCheck and Traditional Tonometer (Goldmann and Tonopen) EyeCheck pressures will be measured with contact lens in place EyeCheck: EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes. Pressures will be measured with both Goldmann and Tonopen (both traditional tonometers to take the intraocular pressure (IOP) measurements of the eye). Traditional Tonometer (Goldmann and Tonopen): Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck.

Overall Study Screen fail

1

Baseline Characteristics

Reliability and Reproducibility of the Eye Check Tonometer

Baseline characteristics by cohort

Measure	EyeCheck and Traditional Tonometer (Goldmann and Tonopen) n=22 Participants EyeCheck pressures will be measured with contact lens in place EyeCheck: EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes. Pressures will be measured with both Goldmann and Tonopen (both traditional tonometers to take the intraocular pressure (IOP) measurements of the eye). Traditional Tonometer (Goldmann and Tonopen): Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 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	2 Participants n=5 Participants
Race (NIH/OMB) White	17 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 States	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Participants received both EyeCheck and traditional tonometer measurements.

Compare EyeCheck intraocular pressure (IOP) measurements comparable to those of traditional tonometers (Goldmann and tonopen)

Outcome measures

Measure	EyeCheck n=22 eyes EyeCheck pressures will be measured with contact lens in place EyeCheck: EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes.	Traditional Tonometer (Goldmann and Tonopen) n=22 eyes Pressures will be measured with both Goldmann and Tonopen (both traditional tonometers to take the intraocular pressure (IOP) measurements of the eye). Traditional Tonometer (Goldmann and Tonopen): Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck.
Intraocular Pressure (IOP) Measurements	17.4 mmHg Interval 10.0 to 26.0	19.1 mmHg Interval 13.0 to 25.0

Adverse Events

EyeCheck

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Tonometer (Goldmann and Tonopen)

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

Dr. Sanjay Asrani

Duke Eye Center

Phone: +1 919 684 8656

Email: sanjay.asrani@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place