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

NCT01621503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2013-06-28

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

NT-530P

intraocular pressure and central corneal thickness measurement

Sponsors & Collaborators

  • Nidek Co. LTD.

    lead INDUSTRY

Study Design

Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01621503 on ClinicalTrials.gov