Trial Outcomes & Findings for Clinical Study for TONOREF III Tested to ANSI Z80.10-2014 (NCT NCT07152808)
NCT ID: NCT07152808
Last Updated: 2026-04-24
Results Overview
Agreement of the measured IOP between the test device and the predicate device (GAT) for the tonometer function of the TONOREF III. (Agreement means the similarity of results when measurements from the test device and the predicate device are compared against each other.)
Recruitment status
COMPLETED
Target enrollment
52 participants
Primary outcome timeframe
1-2 study visits per subject over the course of 8 days
Results posted on
2026-04-24
Participant Flow
Participant milestones
| Measure |
TONOREF III and Goldmann Tonometer Measurements
Subjects will undergo IOP measurements using both the investigational device (TONOREF III) and the predicate device (Goldmann Applanation Tonometer).
NIDEK TONOREF III: The auto ref/kerato/tono/pachymeter TONOREF III is a medical device which measures objective refractive errors, corneal curvature radius, intraocular pressure and corneal thickness of the patient's eye.
Haag-Streit Goldmann Manual Tonometer: Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
TONOREF III and Goldmann Tonometer Measurements
Subjects will undergo IOP measurements using both the investigational device (TONOREF III) and the predicate device (Goldmann Applanation Tonometer).
NIDEK TONOREF III: The auto ref/kerato/tono/pachymeter TONOREF III is a medical device which measures objective refractive errors, corneal curvature radius, intraocular pressure and corneal thickness of the patient's eye.
Haag-Streit Goldmann Manual Tonometer: Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma
|
|---|---|
|
Overall Study
screening failure
|
10
|
Baseline Characteristics
Clinical Study for TONOREF III Tested to ANSI Z80.10-2014
Baseline characteristics by cohort
| Measure |
TONOREF III and Goldmann Tonometer Measurements
n=42 Participants
Subjects will undergo IOP measurements using both the investigational device (TONOREF III) and the predicate device (Goldmann Applanation Tonometer).
NIDEK TONOREF III: The auto ref/kerato/tono/pachymeter TONOREF III is a medical device which measures objective refractive errors, corneal curvature radius, intraocular pressure and corneal thickness of the patient's eye.
Haag-Streit Goldmann Manual Tonometer: Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma
|
|---|---|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=2 Participants
|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 12.74 • n=2 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: 1-2 study visits per subject over the course of 8 daysAgreement of the measured IOP between the test device and the predicate device (GAT) for the tonometer function of the TONOREF III. (Agreement means the similarity of results when measurements from the test device and the predicate device are compared against each other.)
Outcome measures
| Measure |
TONOREF III and Goldmann Tonometer Measurements
n=80 eyes
Subjects will undergo IOP measurements using both the investigational device (TONOREF III) and the predicate device (Goldmann Applanation Tonometer).
NIDEK TONOREF III: The auto ref/kerato/tono/pachymeter TONOREF III is a medical device which measures objective refractive errors, corneal curvature radius, intraocular pressure and corneal thickness of the patient's eye.
Haag-Streit Goldmann Manual Tonometer: Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma
|
|---|---|
|
Agreement of Intraocular Pressure
NIDEK TONOREF III
|
18.4 mmHg
Standard Deviation 4.50
|
|
Agreement of Intraocular Pressure
Haag-Streit GAT
|
18.3 mmHg
Standard Deviation 5.11
|
SECONDARY outcome
Timeframe: 1-2 study visits per subject over the course of 8 daysPopulation: No subject had an AE.
To demonstrate that the test device is as safe as GAT
Outcome measures
| Measure |
TONOREF III and Goldmann Tonometer Measurements
n=52 Participants
Subjects will undergo IOP measurements using both the investigational device (TONOREF III) and the predicate device (Goldmann Applanation Tonometer).
NIDEK TONOREF III: The auto ref/kerato/tono/pachymeter TONOREF III is a medical device which measures objective refractive errors, corneal curvature radius, intraocular pressure and corneal thickness of the patient's eye.
Haag-Streit Goldmann Manual Tonometer: Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma
|
|---|---|
|
The Numbers of Adverse Events
|
0 Number of Adverse Event
|
Adverse Events
TONOREF III and Goldmann Tonometer Measurements
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place