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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults 18 years old or older | Experimental | Nidek Tonoref III |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nidek Tonoref III | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Occurrences of Adverse Events | Any sight threatening adverse event associated with the test and predicate devices. | 1day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2017 |
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| Haag-Streit Goldmann Manual Tonometer | Device | Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma |
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| NIDEK CEM-530 | Device | 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. |
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| COMPLETED |
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| NOT COMPLETED |
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A total of 225 subjects were enrolled in the study and comprised the safety population; 224 subjects completed the study. One subject was discontinued due to a protocol violation. 223 subjects were included in the CCT Efficacy Subpopulation. One subject was excluded from the CCT Efficacy Subpopulation due to unevaluable results.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Iris Color | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data of subjects with 500-600µm CCT and ≤3D Astigmatism. | Posted | Mean | Standard Deviation | mmHg | 1 day |
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| 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. | Subjects with 300-800 μm CCT (Predicate) | Posted | Mean | Standard Deviation | μm | 1 day |
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| Secondary | Number of Occurrences of Adverse Events | Any sight threatening adverse event associated with the test and predicate devices. | Adverse Events were monitored irrespective of specific device and therefore cannot be separated. | Posted | Count of Participants | Participants | 1day |
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1day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NIDEK TONOREF III Comparison | Adverse Events were monitored irrespective of specific device and therefore cannot be separated. | 0 | 225 | 0 | 225 | 1 | 225 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Punctate epithelial erosions | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tadakazu Ichimura | NIDEK Co., LTD. | +81-533-67-8904 | tadakazu_ichimura@nidek.co.jp |
| Jun 29, 2023 |
| Prot_SAP_001.pdf |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Hazel |
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| Green |
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| Grey |
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| Other |
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