Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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)
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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;
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Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
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Subjects who agree to participate in the study;
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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.
Trial design
65 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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