NCT01621503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 28, 2013

Status Verified

July 1, 2012

Enrollment Period

1.8 years

First QC Date

June 14, 2012

Last Update Submit

June 26, 2013

Conditions

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

Outcome Measures

Primary Outcomes (2)

  • central corneal thickness

    one day

  • intraocular pressure

    one day

Interventions

NT-530PDEVICE

intraocular pressure and central corneal thickness measurement

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaiya ophthalmological clinic

Hamamatsu, Shizuoka, 430-0903, Japan

Location

Ochanomizu Inoue ophthalmological clinic

Tokyo, Japan

Location

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2012

First Posted

June 18, 2012

Study Start

April 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 28, 2013

Record last verified: 2012-07

Locations

JP(2)