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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.

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.

Condition or disease Intervention/treatment
Corneal Endothelial Cell Loss Device: Topcon Specular Microscope SP-1P Device: Konan Specular Microscope CELLCHEK XL

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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : February 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : September 2014

Group/Cohort Intervention/treatment
Non-Pathologic Adults age 18-28 yrs
Non-Pathologic Adults age 18-28 yrs
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
Device: Topcon Specular Microscope SP-1P
Device: Konan Specular Microscope CELLCHEK XL
Pathologic Adults age 29-80 yrs
Pathologic Adults age 29-80 yrs
Device: Topcon Specular Microscope SP-1P
Device: Konan Specular Microscope CELLCHEK XL



Primary Outcome Measures :
  1. Corneal endothelial cell density [ Time Frame: Single time point - 1 day ]
  2. Coefficient of variation of endothelial cell area [ Time Frame: Single time point - 1 day ]
  3. Corneal endothelial cell % hexagonality [ Time Frame: Single time point - 1 day ]
  4. Central corneal thickness [ Time Frame: Single time point - 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ophthalmology Practice
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.

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): NCT02138266


Locations
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United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Topcon Medical Systems, Inc.
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Responsible Party: Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT02138266    
Other Study ID Numbers: TOPCON-SP-1P-US-0001
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: November 2014
Additional relevant MeSH terms:
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Corneal Endothelial Cell Loss
Corneal Diseases
Eye Diseases
Postoperative Complications
Pathologic Processes