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

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ClinicalTrials.gov Identifier: NCT01621503
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : June 28, 2013
Sponsor:
Information provided by (Responsible Party):
Nidek Co. LTD.

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.

Condition or disease Intervention/treatment Phase
IOP Ranges(mmHg): 7 to 16, >16 to <23, and 23 or More Device: NT-530P Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Comparative Clinical Study to Investigate the Use of the NON CONTACT TONO/PACHYMETER NT-530P
Study Start Date : April 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

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


Primary Outcome Measures :
  1. central corneal thickness [ Time Frame: one day ]
  2. intraocular pressure [ Time Frame: one day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621503


Locations
Japan
Kaiya ophthalmological clinic
Hamamatsu city, Shizuoka, Japan, 430-0903
Ochanomizu Inoue ophthalmological clinic
Tokyo, Japan
Sponsors and Collaborators
Nidek Co. LTD.

Responsible Party: Nidek Co. LTD.
ClinicalTrials.gov Identifier: NCT01621503     History of Changes
Other Study ID Numbers: NT530P-120210
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: July 2012