Corneal Elastography and Patient Specific Modeling



Status:Recruiting
Conditions:Ocular, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Ophthalmology
Healthy:No
Age Range:16 - 80
Updated:2/1/2018
Start Date:May 2016
End Date:May 2018
Contact:Pamela Hoffman, MS
Email:moorehp@ccf.org
Phone:216-445-5248

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The goal of this research is to develop measurement tools and simulation technology for
characterizing and predicting individual responses to corneal treatments and for advancing
understanding of corneal ectasia risk factors. Patients who either 1) have keratoconus and
are being evaluated for corneal crosslinking or 2) have refractive error and are being
evaluated for refractive surgery procedures such as LASIK will have their eyes imaged to
assess their mechanical properties and will have computational simulations performed to
predict the response to treatment. One aim of the study is to test the hypothesis that
computational models can predict the cornea's shape changes within clinically acceptable
limits of error.

The mechanical condition of the cornea is an important but elusive property of the eye to
characterize. Weakness in the cornea is thought to be one of the primary causes of corneal
ectasia, a major cause of visual impairment worldwide. Corneal weakness is also important to
identify in refractive surgery candidates since such surgeries often involve tissue removal
that could lead to corneal instability in certain predisposed patients.

In this study, subjects will undergo imaging with an optical coherence tomography (OCT)-based
system to characterize corneal biomechanical properties. In addition, computational
representations of the eye will be built from images and interventions will be simulated and
compared to actual treatment outcomes. No investigational procedures or study-specific
interventions other than imaging are involved.

Inclusion Criteria:

- Any patient with keratoconus diagnosed by standard criteria, including topographic
steepness, irregular astigmatism with a pattern consistent with keratoconus.

- Any patient deemed a candidate for LASIK (laser vision correction) and scheduled for
surgery.

Exclusion Criteria:

- Inability to provide informed consent, including non-English speaking (if interpreter
not available) and cognitively/mentally impaired (if legal guardian not available).
We found this trial at
1
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Cleveland, Ohio 44195
Phone: 216-445-5248
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