Comparative Study of the NIDEK TONOREF III and the Haag-Streit Goldmann Manual Tonometer and Comparison of Pachymetry Values for NIDEK TONOREF III With the NIDEK CEM-530

• Sponsor: Nidek Co. LTD. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03441477
• Collaborator: (none)
• Enrollment: 225
• Location: 1
• Arm: 1
• Actual Duration (Months): 13
• Patients Per Site Per Month: 17.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraocular Pressure	Device: Nidek Tonoref III; Device: Haag-Streit Goldmann Manual Tonometer; Device: NIDEK CEM-530

Study Design

• Study Type: Interventional
• Actual Enrollment: 225 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Comparative Study of the NIDEK TONOREF III and the Haag-Streit Goldmann Manual Tonometer (Predicate) to Demonstrate Conformance to ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the Applicable Supplemental Information Sheet and Comparison of Pachymetry Values for NIDEK TONOREF III With the NIDEK CEM-530 (Predicate)
• Actual Study Start Date: Dec 17, 2017
• Actual Primary Completion Date: Jan 16, 2019
• Actual Study Completion Date: Jan 16, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Adults 18 years old or older Nidek Tonoref III

Device: 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.; Device: Haag-Streit Goldmann Manual Tonometer; Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma; Device: NIDEK 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. Number of Occurrences of Adverse Events [1day]

   Any sight threatening adverse event associated with the test and predicate devices.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Andover Eye Associates	Andover	Massachusetts	United States	01810

Sponsors and Collaborators

• Nidek Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 7, 2017

More Information

Publications

None provided.

• Responsible Party: Nidek Co. LTD.
• ClinicalTrials.gov Identifier: NCT03441477
• Other Study ID Numbers: NIDEK-TONOREF-US-0001
• First Posted: Feb 22, 2018
• Last Update Posted: Apr 5, 2022
• Last Verified: Jan 1, 2022

Study Results

Participant Flow

Arm/Group Title	NIDEK TONOREF III Comparison
Arm/Group Description	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.
Period Title: Overall Study
STARTED	225
COMPLETED	224
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	NIDEK TONOREF III Comparison
Arm/Group Description	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.
Overall Participants	223
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.5 (13.10)
Sex: Female, Male (Count of Participants)
Female	126 56.5%
Male	97 43.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	13 5.8%
Not Hispanic or Latino	210 94.2%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	8 3.6%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	46 20.6%
White	168 75.3%
More than one race	1 0.4%
Unknown or Not Reported	0 0%
Iris Color (Count of Participants)
Black	8 3.6%
Blue	49 22%
Brown	126 56.5%
Hazel	28 12.6%
Green	10 4.5%
Grey	1 0.4%
Other	1 0.4%

Outcome Measures

1. Primary Outcome

Title	Agreement of Intraocular Pressure
Description	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

Outcome Measure Data

Analysis Population Description

Data of subjects with 500-600µm CCT and ≤3D Astigmatism.

Arm/Group Title	NIDEK TONOREF III Comparison
Arm/Group Description	IOP value were compared between NIDEK TONOREF III and Haag-Streit GAT
Measure Participants	120
Mean (Standard Deviation) [mmHg]	0.3 (3.45)

2. Primary Outcome

Title	Agreement of Corneal Thickness
Description	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

Outcome Measure Data

Analysis Population Description

Subjects with 300-800 μm CCT (Predicate)

Arm/Group Title	NIDEK TONOREFIII Comparison
Arm/Group Description	CCT were compared between NIDEK TONOREF III and NIDEK CEM-530.
Measure Participants	223
Mean (Standard Deviation) [μm]	-7.1 (8.31)

3. Secondary Outcome

Title	Number of Occurrences of Adverse Events
Description	Any sight threatening adverse event associated with the test and predicate devices.
Time Frame	1day

Outcome Measure Data

Analysis Population Description

Adverse Events were monitored irrespective of specific device and therefore cannot be separated.

Arm/Group Title	NIDEK TONOREF III Comparison
Arm/Group Description	Adverse Events were monitored irrespective of specific device and therefore cannot be separated.
Measure Participants	225
Count of Participants [Participants]	1 0.4%

Adverse Events

Time Frame	1day
Arm/Group Title	NIDEK TONOREF III Comparison
Arm/Group Description	Adverse Events were monitored irrespective of specific device and therefore cannot be separated.
All Cause Mortality
	NIDEK TONOREF III Comparison
	Affected / at Risk (%)	# Events
Total	0/225 (0%)
Serious Adverse Events
	NIDEK TONOREF III Comparison
	Affected / at Risk (%)	# Events
Total	0/225 (0%)
Other (Not Including Serious) Adverse Events
	NIDEK TONOREF III Comparison
	Affected / at Risk (%)	# Events
Total	1/225 (0.4%)
Eye disorders
Punctate epithelial erosions	1/225 (0.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.