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

Nidek Co. LTD.2 sites in 1 country250 target enrollmentApril 2011

ConditionsIOP Ranges(mmHg): 7 to 16, >16 to <23, and 23 or More

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: IOP Ranges(mmHg): 7 to 16, >16 to <23, and 23 or More
Sponsor: Nidek Co. LTD.
Enrollment: 250
Locations: 2
Primary Endpoint: central corneal thickness
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

January 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nidek Co. LTD.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•IOP Measurement
•Those with only one functional eye
•Those with one eye having poor or eccentric fixation
•Those with corneal scarring or who have had corneal surgery such as laser surgery
•Microphthalmus
•Buphthalmos
•Contact lens wearers
•Blepharospasm
•Keratoconus
•Those who have been diagnosed as having corneal conjunctivitis or other infectious disease