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Completed

NCT Number: NCT01621503

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

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiya ophthalmological clinic, Hamamatsu, Shizuoka, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

NT-530P

Device

intraocular pressure and central corneal thickness measurement

Primary outcomes

  1. central corneal thickness

    Time frame: one day

  2. intraocular pressure

    Time frame: one day

Sponsors and collaborators

Lead sponsor

Nidek Co. LTD.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 18, 2012
Registry last updated
Jun 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.