Clinical trial NCT02478970: Specular Microscopy Study
Official title: Comparison of Clinical Evaluation of Endothelial Cells With Paracentral and Central Specular Microscopy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Endotheliopathies
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The corneal endothelium plays an important role in regulating stromal hydration and maintaining the transparency of the cornea. For evaluating the cornea, the most important parameters are corneal endothelial morphology and central corneal thickness. The specular microscope does this. The image in specular microscope is obtained by the specular reflex at a regular, smooth-surfaced interface of two refractive indices, with the angle of the light passing into the cornea equal to the angle of reflection to the observer. To obtain a clear image, the endothelial apical surface must be smooth and uniform and the cornea must be transparent. Nowadays different types of specular microscope exist.

The investigators propose to compare the endothelial cells with two specular microscopes: the Konan SP4000, which is the current model and used for standard of care, to the Nidek CEM-350, which is a newly marketed device.

The investigators would like to evaluate the patients in the clinic and have assessments completed with both specular microscopes.

Nidek will be loaning the specular microscope, NIDEK CEM-530, for the study.

Detailed description: Subjects that provide informed consent will be clinically evaluated (visual acuity, refraction, slit-lamp biomicroscopy, tonometry) by a corneal specialist. After endothelium evaluation with use of slit-lamp biomicroscopy a grade of severity will be given. The grades will be based on the density and confluence of guttae and presence of clinical edema.

Two microscopes, non-contact specular microscope (KONAN SP4000) and paracentral non-contact specular microscope (NIDEK CEM-350), will be used for the exam.

For each patient both eyes will be examined by the two non-contact specular microscopes.

Three pictures of the central cornea will be captured from the standard specular microscope.

The paracentral specular microscope can capture image of one central point, eight paracentral points with 5° visual angle and six peripheral points with 27° visual angle. It will capture 16 images and automatically will classify based on quality and the ability to be analyzed. The optimal image for analysis will be indicated with orange highlight. Once the image is selected, a new manual or automatic software will be used to count the endothelial cells, complete analysis will be automatically performed.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older;
* Patients with primary corneal endotheliopathies (posterior polymorphous dystrophy, congenital hereditary endothelial dystrophy, Fuchs' dystrophy, iridocorneal endothelial syndrome;
* Healthy patients without corneal endotheliopathies.

Exclusion Criteria:

* Patients with history of corneal and/or intraocular surgery;
* Patients with existing corneal and/or anterior segment disease, except for the inclusion criteria;
* Intraocular pressure ≥21mmHg;
* Contact lens wearer;
* History of ocular trauma;
* Patients with diabetes mellitus.

Primary outcomes:
measure: Endothelial cell count
timeFrame: Approximately at the end of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Kellogg Eye Center
state: Michigan
Study officials:
affiliation: University of Michigan Kellogg Eye Center
name: Shahzad Mian, MD
role: PRINCIPAL_INVESTIGATOR
References: