Intraocular Pressure
Conditions
Brief summary
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.
Interventions
DEVICENIDEK 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 measures intraocular pressure to aid in the screening and diagnosis of glaucoma
Sponsors
Nidek Co. LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Each subject had to have: 1. been at least 22 years of age of either sex and any race or ethnicity; 2. been willing and able to provide written informed consent prior to any study procedures being performed; 3. been willing and able to follow all instructions and attend all study visits; 4. corneal astigmatism of ≤3D and corneal thickness of 500-600 μm in at least one eye.
Exclusion criteria
Each subject had to not to : 1. have only one functional eye; 2. have poor or eccentric fixation in the study eye; 3. have corneal scarring or have had corneal surgery, including corneal laser surgery in the study eye 4. have microphthalmos in the study eye; 5. have buphthalmos in the study eye; 6. be a contact lens wearer in the study eye; 7. have dry eyes; 8. be a lid squeezer - blepharospasm; 9. have nystagmus in the study eye; 10. have keratoconus in the study eye; 11. have any other corneal or conjunctival pathology or infection in the study eye; 12. use medication that affect IOP; 13. current participation in other clinical trials; 14. have a condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement of Intraocular Pressure | 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.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Numbers of Adverse Events | 1-2 study visits per subject over the course of 8 days | To demonstrate that the test device is as safe as GAT |
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 12.74 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 37 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 52 |
| other Total, other adverse events | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 |
Outcome results
None listed