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Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements

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ClinicalTrials.gov Identifier: NCT02138266
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
Topcon Medical Systems, Inc.

Tracking Information
First Submitted Date May 5, 2014
First Posted Date May 14, 2014
Last Update Posted Date April 24, 2015
Study Start Date February 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 12, 2014)
  • Corneal endothelial cell density [ Time Frame: Single time point - 1 day ]
  • Coefficient of variation of endothelial cell area [ Time Frame: Single time point - 1 day ]
  • Corneal endothelial cell % hexagonality [ Time Frame: Single time point - 1 day ]
  • Central corneal thickness [ 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 Specular Microscopes for Endothelial and Corneal Cell Measurements
Official Title Comparative Study of the Topcon Specular Microscope SP-1P and the Konan Specular Microscope CELLCHEK XL (Predicate Device) for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area, % Hexagonality, Central Corneal Thickness
Brief Summary The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Topcon Specular Microscope SP-1P. 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 Corneal Endothelial Cell Loss
Intervention
  • Device: Topcon Specular Microscope SP-1P
  • Device: Konan Specular Microscope CELLCHEK XL
Study Groups/Cohorts
  • Non-Pathologic Adults age 18-28 yrs
    Non-Pathologic Adults age 18-28 yrs
    Interventions:
    • Device: Topcon Specular Microscope SP-1P
    • Device: Konan Specular Microscope CELLCHEK XL
  • Non-Pathologic Adults age 29-80 yrs
    Non-Pathologic Adults age 29-80 yrs
    Interventions:
    • Device: Topcon Specular Microscope SP-1P
    • Device: Konan Specular Microscope CELLCHEK XL
  • Pathologic Adults age 29-80 yrs
    Pathologic Adults age 29-80 yrs
    Interventions:
    • Device: Topcon Specular Microscope SP-1P
    • Device: Konan Specular Microscope CELLCHEK XL
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: May 12, 2014)
65
Original Actual Enrollment Same as current
Actual Study Completion Date September 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria -Non-Pathologic Young Adults (18-28 years old) and Non-Pathologic Adults (29-80 years old):

  • Male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed;
  • Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
  • Subjects who agree to participate in the study.

Inclusion Criteria -Pathologic Adults (29-80 years old)

  • Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed;
  • Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
  • Subjects who agree to participate in the study;
  • At least one eye with any of the following conditions:

    • History of post-op surgical trauma including Pseudophakic or Aphakic bullous keratopathy;
    • History of corneal transplant;
    • Physical injury or trauma to the cornea;
    • Long term Fuch's dystrophy/Guttata (and other corneal endothelial dystrophies)
    • Keratoconus;
    • Long term PMMA contact lens use (greater than 3 years).

Exclusion Criteria -Non-Pathologic Young Adults (18-28 years old) and Non Pathologic Adults (29-80 years old)

  • History of corneal transplant;
  • Long term Fuch's dystrophy (and other corneal endothelial dystrophies);
  • Keratoconus;
  • Guttata;
  • Diabetes mellitus type I or type II;
  • History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device;
  • All contact lens wearers;
  • Fixation problems which may prevent obtaining good quality SP-1P and CELLCHEK PLUS in either eye.

Exclusion Criteria -Pathologic Adults (29-80 years old):

  • Fixation problems which may prevent obtaining at least poor quality (refer to Figure 1) SP-1P and KONAN CELLCHEK PLUS images in either eye.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02138266
Other Study ID Numbers TOPCON-SP-1P-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