Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT02138266
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02138266
Study Brief:
Protocol Section:
NCT02138266