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Comparative Study of Non-contact Tonometers for Intraocular Pressure and Corneal Cell Thickness Measurements

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138279
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : April 23, 2015
Sponsor:
Information provided by (Responsible Party):
Topcon Medical Systems, Inc.

Tracking Information
First Submitted Date April 23, 2014
First Posted Date May 14, 2014
Last Update Posted Date April 23, 2015
Study Start Date April 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 12, 2014)
  • Agreement of intraocular pressure measurements from predicate vs. investigational device [ Time Frame: Single timepoint - 1 day ]
  • Agreement of central corneal thickness measurements from predicate vs. investigational device [ Time Frame: Single time point - 1 day ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparative Study of Non-contact Tonometers for Intraocular Pressure and Corneal Cell Thickness Measurements
Official Title Comparative Study of the Topcon Tonometers - CT-800, CT-1, CT-1P and TRK-2P to Demonstrate Conformance to ANSI Z80.10-2009 Ophthalmic Instruments -Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the Applicable Supplemental Information Sheet and Comparison of Pachymetry Values for CT-1P and TRK-2P With the Konan CellChek Plus (Predicate)
Brief Summary The primary objective of this clinical study is to collect clinical data to support FDA 510(k) submissions for the Topcon CT-800, CT-1, CT-1P and TRK-2P non-contact tonometers. The secondary objective is to evaluate any adverse events found during the clinical study.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Ophthalmology practice
Condition
  • Intraocular Pressure
  • Corneal Pachymetry
Intervention Not Provided
Study Groups/Cohorts Male and female adults 18+ years of age
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 22, 2015)
65
Original Estimated Enrollment
 (submitted: May 12, 2014)
225
Actual Study Completion Date December 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • At least 18 years of age of either sex and any race or ethnicity;
  • Willing and able to provide written informed consent prior to any study procedures being performed;
  • Willing and able to follow all instructions and attend all study visits;
  • Best Spectacle Corrected Visual Acuity (BSCVA) of 0.3 logMAR (20/40 Snellen equivalent) or better in both eyes as measured using an ETDRS chart.

Exclusion Criteria:

  • Only one functional eye;
  • Poor or eccentric fixation;
  • Corneal scarring or have had corneal surgery, including corneal laser surgery;
  • Microphthalmos;
  • Buphthalmos;
  • Contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months;
  • Dry eyes, meaning having been diagnoses by a physician with dry eyes and currently using a prescribed medication;
  • Lid squeezer - blepharospasm;
  • Nystagmus;
  • Keratoconus;
  • Any other corneal or conjunctival pathology or infection;
  • Condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02138279
Other Study ID Numbers TOPCON-TON-US-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Topcon Medical Systems, Inc.
Study Sponsor Topcon Medical Systems, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Topcon Medical Systems, Inc.
Verification Date November 2014