Prospective Comparative Clinical Study to Investigate the Use of the NON CONTACT TONO/PACHYMETER NT-530P

The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek Non Contact Tono/ Pachymeter NT-530P. The secondary objective is to evaluate any adverse events found during the clinical study.

Study Overview

• Status: Completed
• Conditions: IOP Ranges(mmHg): 7 to 16, >16 to <23, and 23 or More
• Intervention / Treatment: Device: NT-530P

Detailed Description

Following data analysis will be conducted for tonometer and pachymeter readings. One of eyes of one patient becomes an object of the analysis. Regarding the intraocular pressure, higher IOP readings of either right or left eye are used for analysis. Regarding CCT, the readings of either right or left eye are randomly assigned to analysis in the order of registration.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Ochanomizu Inoue ophthalmological clinic
  • Shizuoka
    • Hamamatsu city, Shizuoka, Japan, 430-0903
      • Kaiya ophthalmological clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. IOP Measurement 1. 20 years or older who voluntarily agree to participate in this study after receiving adequate explanation 2. Possible to participate in the study regardless of existence of glaucoma
2. CCT Measurement 1. 20 years or older who voluntarily agree to participate in this study after receiving adequate explanation 2. Possible to participate in the study regardless of existence of glaucoma 3. Possible to participate in the study regardless of existence of corneal diseases (such as Keratoconus, post-LASIK, and corneal scars)

Exclusion Criteria:

1. IOP Measurement 1. Those with only one functional eye 2. Those with one eye having poor or eccentric fixation 3. Those with corneal scarring or who have had corneal surgery such as laser surgery 4. Microphthalmus 5. Buphthalmos 6. Contact lens wearers 7. Dry eyes 8. Blepharospasm 9. Nystagmus 10. Keratoconus 11. Those who have been diagnosed as having corneal conjunctivitis or other infectious disease 12. Those with central corneal thickness greater than 600 μm or less than 500 μm 13. A subject judged to be ineligible for participating in the study by the physicians in charge
2. CCT Measurement 1. Those with only one functional eye 2. Those with one eye having poor or eccentric fixation 3. Blepharospasm 4. Nystagmus 5. Those who have been diagnosed as having corneal conjunctivitis or other infectious disease 6. A subject judged to be ineligible for participating in the study by the physicians in charge

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
central corneal thickness	one day
intraocular pressure	one day

Collaborators and Investigators

• Sponsor: Nidek Co. LTD.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: June 14, 2012
• First Submitted That Met QC Criteria: June 14, 2012
• First Posted (Estimate): June 18, 2012

Study Record Updates

• Last Update Posted (Estimate): June 28, 2013
• Last Update Submitted That Met QC Criteria: June 26, 2013
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: NT530P-120210