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

Not Applicable

Completed

• Conditions: IOP Ranges(mmHg): 7 to 16, >16 to <23, and 23 or More

• Registration Number: NCT01621503
• Lead Sponsor: Nidek Co. LTD.

Brief Summary

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.

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 Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-06-14
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-18
• Status Verified: 2012-07
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-06-26
• Last Update Posted: 2013-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
central corneal thickness	one day
intraocular pressure	one day

Trial Locations

Locations (2)

Kaiya ophthalmological clinic; 🇯🇵 Hamamatsu city, Shizuoka, Japan

Ochanomizu Inoue ophthalmological clinic; 🇯🇵 Tokyo, Japan