Trials / Completed
CompletedNCT01621503
Prospective Comparative Clinical Study to Investigate the Use of the NON CONTACT TONO/PACHYMETER NT-530P
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 250 (actual)
- Sponsor
- Nidek Co. LTD. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NT-530P | intraocular pressure and central corneal thickness measurement |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2013-01-01
- Completion
- 2013-01-01
- First posted
- 2012-06-18
- Last updated
- 2013-06-28
Locations
2 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01621503. Inclusion in this directory is not an endorsement.