Nidek Tonoref III
DeviceThe 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.
NCT Number: NCT07152808
The primary objective of this clinical study was to show that tonometry values for TONOREF III, as the representative device of the NIDEK tonometer series, were comparable to the predicate device.
The secondary objective was to demonstrate that the test device was as safe as the predicate device.
Looking for future studies?
Notify Me22 year and older
All sexes
Interventional
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Each subject had to have:
Exclusion criteria
Each subject had to not to :
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 measures intraocular pressure to aid in the screening and diagnosis of glaucoma
Time frame: 1-2 study visits per subject over the course of 8 days
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.)
Time frame: 1-2 study visits per subject over the course of 8 days
To demonstrate that the test device is as safe as GAT
Nidek Co. LTD.
Industry
Clinical Pilot Study to Provide Research Data for TONOREF III Tested to ANSI Z80.10-2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04281017
Intraocular Pressure, Neoplasms
Gainesville, Florida, United States
View Trial DetailsNCT07274176
Intraocular Pressure
Uşak, Turkey (Türkiye)
View Trial DetailsNCT07701278
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Banhā, Benha, Egypt
View Trial DetailsNCT07604428
Apnea, Eye Diseases
Olomouc, Czechia
View Trial Details