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Specular Microscopy Study

NCT02478970 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-04-28

No results posted yet for this study

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.

Conditions

  • Endotheliopathies

Interventions

DEVICE

Konan SP4000

current standard of care at Kellogg Eye Center

DEVICE

NIDEK CEM-350

newly marketed device

Sponsors & Collaborators

Principal Investigators

  • Shahzad Mian, MD · University of Michigan Kellogg Eye Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-05-31
Completion
2016-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02478970 on ClinicalTrials.gov