Trial Outcomes & Findings for Comparative Study of the NIDEK TONOREF III and the Haag-Streit Goldmann Manual Tonometer and Comparison of Pachymetry Values for NIDEK TONOREF III With the NIDEK CEM-530 (NCT NCT03441477)

Last Updated: 2023-07-03

Results Overview

Agreement of the measured IOP between the test device and the predicate device for the tonometer function of NIDEK TONOREF III. The mean difference and the standard deviation between these two devices are shown in the outcome measures table.

Recruitment status

COMPLETED

Target enrollment

225 participants

Primary outcome timeframe

1 day

Results posted on

2023-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	NIDEK TONOREF III Comparison Adults, 18 years old or older, were enrolled in this study. Participants were measured by the NIDEK TONOREF III and the Haag-Streit GAT and the NIDEK CEM-530, or the NIDEK TONOREF III and the NIDEK CEM-530.
Overall Study STARTED	225
Overall Study COMPLETED	224
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Study of the NIDEK TONOREF III and the Haag-Streit Goldmann Manual Tonometer and Comparison of Pachymetry Values for NIDEK TONOREF III With the NIDEK CEM-530

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NIDEK TONOREF III Comparison n=223 Participants Adults, 18 years old or older, were enrolled in this study. Participants were measured by the NIDEK TONOREF III and the Haag-Streit GAT and the NIDEK CEM-530, or the NIDEK TONOREF III and the NIDEK CEM-530.
Age, Continuous	60.5 years STANDARD_DEVIATION 13.10 • n=5 Participants
Sex: Female, Male Female	126 Participants n=5 Participants
Sex: Female, Male Male	97 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	210 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 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	46 Participants n=5 Participants
Race (NIH/OMB) White	168 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Iris Color Black	8 Participants n=5 Participants
Iris Color Blue	49 Participants n=5 Participants
Iris Color Brown	126 Participants n=5 Participants
Iris Color Hazel	28 Participants n=5 Participants
Iris Color Green	10 Participants n=5 Participants
Iris Color Grey	1 Participants n=5 Participants
Iris Color Other	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Data of subjects with 500-600µm CCT and ≤3D Astigmatism.

Outcome measures

Outcome measures
Measure	NIDEK TONOREF III Comparison n=120 Participants IOP value were compared between NIDEK TONOREF III and Haag-Streit GAT
Agreement of Intraocular Pressure	0.3 mmHg Standard Deviation 3.45

PRIMARY outcome

Timeframe: 1 day

Population: Subjects with 300-800 μm CCT (Predicate)

Agreement of the measured corneal thickness between the test device and the predicate device for the pachymeter function of the NIDEK TONOREF III. The mean difference and the standard deviation between these two devices are shown in the outcome measure table.

Outcome measures

Outcome measures
Measure	NIDEK TONOREF III Comparison n=223 Participants IOP value were compared between NIDEK TONOREF III and Haag-Streit GAT
Agreement of Corneal Thickness	-7.1 μm Standard Deviation 8.31

SECONDARY outcome

Timeframe: 1day

Population: Adverse Events were monitored irrespective of specific device and therefore cannot be separated.

Any sight threatening adverse event associated with the test and predicate devices.

Outcome measures

Outcome measures
Measure	NIDEK TONOREF III Comparison n=225 Participants IOP value were compared between NIDEK TONOREF III and Haag-Streit GAT
Number of Occurrences of Adverse Events	1 Participants

Adverse Events

NIDEK TONOREF III Comparison

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	NIDEK TONOREF III Comparison n=225 participants at risk Adverse Events were monitored irrespective of specific device and therefore cannot be separated.
Eye disorders Punctate epithelial erosions	0.44% 1/225 • Number of events 1 • 1day

Additional Information

Tadakazu Ichimura

NIDEK Co., LTD.

Phone: +81-533-67-8904

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place