Intraocular Pressure
Conditions
Brief summary
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.
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
DEVICENIDEK CEM-530
Nidek CEM-530 is a non-contact ophthalmic microscope, optical pachymeter, and camera used for examination of the corneal endothelium and for measurement of the thickness of the cornea.
Sponsors
Nidek Co. LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. be at least 18 years of age of either sex and any race or ethnicity; 2. be willing and able to provide written informed consent prior to any study procedures being performed; 3. be willing and able to follow all instructions and attend all study visits;
Exclusion criteria
1. have only one functional eye; 2. have poor or eccentric fixation in either eye; 3. have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye; 4. have microphthalmos in either eye; 5. have buphthalmos in either eye; 6. be a contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months; 7. have dry eyes, meaning having been diagnosed by a physician with dry eyes and currently using a prescribed medication or daily use of artificial tears; 8. be a lid squeezer - blepharospasm; 9. have nystagmus in either eye; 10. have keratoconus in either eye; 11. have any other corneal or conjunctival pathology or infection in either eye; 12. 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 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. |
| Agreement of Corneal Thickness | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Occurrences of Adverse Events | 1day | Any sight threatening adverse event associated with the test and predicate devices. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 223 |
| Total | 223 |
Baseline characteristics
| Characteristic | NIDEK TONOREF III Comparison |
|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 13.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 210 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Iris Color Black | 8 Participants |
| Iris Color Blue | 49 Participants |
| Iris Color Brown | 126 Participants |
| Iris Color Green | 10 Participants |
| Iris Color Grey | 1 Participants |
| Iris Color Hazel | 28 Participants |
| Iris Color Other | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 46 Participants |
| Race (NIH/OMB) More than one race | 1 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 | 168 Participants |
| Sex: Female, Male Female | 126 Participants |
| Sex: Female, Male Male | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 225 |
| other Total, other adverse events | 1 / 225 |
| serious Total, serious adverse events | 0 / 225 |
Outcome results
Primary
Agreement of Corneal Thickness
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.
Time frame: 1 day
Population: Subjects with 300-800 μm CCT (Predicate)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NIDEK TONOREF III Comparison | Agreement of Corneal Thickness | -7.1 μm | Standard Deviation 8.31 |
Primary
Agreement of Intraocular Pressure
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.
Time frame: 1 day
Population: Data of subjects with 500-600µm CCT and ≤3D Astigmatism.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NIDEK TONOREF III Comparison | Agreement of Intraocular Pressure | 0.3 mmHg | Standard Deviation 3.45 |
Secondary
Number of Occurrences of Adverse Events
Any sight threatening adverse event associated with the test and predicate devices.
Time frame: 1day
Population: Adverse Events were monitored irrespective of specific device and therefore cannot be separated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NIDEK TONOREF III Comparison | Number of Occurrences of Adverse Events | 1 Participants |