NCT03441477

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

Completed Results posted Last updated 3 July 2023

What this trial tests

trial testing Nidek Tonoref III in Intraocular Pressure in 225 participants. Completed in 16 January 2019.

Timeline

17 December 2017

Primary endpoint
16 January 2019

16 January 2019

Quick facts

Lead sponsor	Nidek Co. LTD.
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	225
Start date	17 December 2017
Primary completion	16 January 2019
Estimated completion	16 January 2019
Sites	1 location across United States

Drugs / interventions tested

• Nidek Tonoref III
• Haag-Streit Goldmann Manual Tonometer
• NIDEK CEM-530

Conditions studied

• Intraocular Pressure — all drugs for Intraocular Pressure →

Sponsor

Nidek Co. LTD.

Who can join

18 and older, any sex, with Intraocular Pressure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Agreement of Intraocular Pressure Primary · 1 day

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.

Group	Value	95% CI
NIDEK TONOREF III Comparison	0.3	± 3.45

Agreement of Corneal Thickness Primary · 1 day

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.

Group	Value	95% CI
NIDEK TONOREFIII Comparison	-7.1	± 8.31

Number of Occurrences of Adverse Events Secondary · 1day

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

Group	Value	95% CI
NIDEK TONOREF III Comparison	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 1day. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

NIDEK TONOREF III Comparison

Serious: 0/225 (0%)

Deaths: 0/225

Other adverse events (1 terms — click to expand)

Reaction	System	NIDEK TONOREF III Comparison
Punctate epithelial erosions	Eye disorders	—

Data from ClinicalTrials.gov NCT03441477 adverse events section.

Sponsor's own description

The primary objective of this clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device. The secondary objective is to demonstrate that the test device is as safe as the predicate devices.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.