Specular Microscopy Study

Withdrawn before enrolling · Not applicable

Conditions studied: Endotheliopathies

In brief

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.

Key facts

Study ID

NCT02478970

Run by

University of Michigan

People needed

0

Starts

2014-06-01

Expected to finish

2016-06-01

Last updated by the study team

2017-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kellogg Eye Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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