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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TONOREF III and Goldmann Tonometer Measurements | Experimental | Subjects will undergo IOP measurements using both the investigational device (TONOREF III) and the predicate device (Goldmann Applanation Tonometer). |
|
| 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 (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.) | 1-2 study visits per subject over the course of 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Numbers of Adverse Events | To demonstrate that the test device is as safe as GAT | 1-2 study visits per subject over the course of 8 days |
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Inclusion Criteria:
Each subject had to have:
Exclusion Criteria:
Each subject had to not to :
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| ID | Title | Description |
|---|---|---|
| FG000 | TONOREF III and Goldmann Tonometer Measurements | Subjects will undergo IOP measurements using both the investigational device (TONOREF III) and the predicate device (Goldmann Applanation Tonometer). NIDEK 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: Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | TONOREF III and Goldmann Tonometer Measurements | Subjects will undergo IOP measurements using both the investigational device (TONOREF III) and the predicate device (Goldmann Applanation Tonometer). NIDEK 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: Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 (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.) | Posted | Mean | Standard Deviation | mmHg | 1-2 study visits per subject over the course of 8 days | eyes | eyes |
|
1 to 8 days
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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 | TONOREF III and Goldmann Tonometer Measurements | Subjects will undergo IOP measurements using both the investigational device (TONOREF III) and the predicate device (Goldmann Applanation Tonometer). NIDEK 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: Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tadakazu Ichimura | NIDEK CO., LTD. | +81-533-67-8904 | tadakazu_ichimura@nidek.co.jp |
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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 | May 16, 2023 | Dec 4, 2025 | Prot_SAP_000.pdf |
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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 |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Secondary | The Numbers of Adverse Events | To demonstrate that the test device is as safe as GAT | No subject had an AE. | Posted | Number | Number of Adverse Event | No | 1-2 study visits per subject over the course of 8 days |
|
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| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
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