Specular Microscopy Study

Comparison of Clinical Evaluation of Endothelial Cells With Paracentral and Central Specular Microscopy

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.

Study Overview

• Status: Withdrawn
• Conditions: Endotheliopathies
• Intervention / Treatment: Device: Konan SP4000; Device: NIDEK CEM-350

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Kellogg Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Corneal endotheliopathy; Patients with primary corneal endotheliopathies, such as posterior polymorphous dystrophy, congenital hereditary endothelial dystrophy, Fuchs' dystrophy, iridocorneal endothelial syndrome will be evaluated with the NIDEK CEM-350 and Konan SP4000	Device: Konan SP4000; current standard of care at Kellogg Eye Center; Device: NIDEK CEM-350; newly marketed device
Placebo Comparator: Normal; Patients without corneal endotheliopathies will be evaluated with the NIDEK CEM-350 and Konan SP4000	Device: Konan SP4000; current standard of care at Kellogg Eye Center; Device: NIDEK CEM-350; newly marketed device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Endothelial cell count	Approximately at the end of 1 year

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: April 24, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HUM00087911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No