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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621503
• Other study ID #: NT530P-120210
• Status: Completed
• Phase: N/A
• First received: June 14, 2012
• Last updated: June 26, 2013
• Start date: April 2011
• Est. completion date: January 2013

Study information

• Verified date: July 2012
• Source: Nidek Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

Device:
• NT-530P
intraocular pressure and central corneal thickness measurement

Locations

Country	Name	City	State
Japan	Kaiya ophthalmological clinic	Hamamatsu city	Shizuoka
Japan	Ochanomizu Inoue ophthalmological clinic	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Nidek Co. LTD.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	central corneal thickness		one day	Yes
Primary	intraocular pressure		one day	Yes