Corneal Elastography and Patient Specific Modeling
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-80
SponsorThe Cleveland Clinic
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Inability to provide informed consent, including non-English speaking (if interpreter not available) and cognitively/mentally impaired (if legal guardian not available).
Trial population
Individuals with refractive error who present for screening for refractive surgery and individuals with keratoconus who are evaluatedat the Cole Eye Institute in Cleveland, Ohio
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Optical coherence tomography
Other intervention
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Predictive accuracy of computational models in corneal surgery
Computational model predictions of corneal interventions will be compared to actual clinical outcomes for each enrolled subject
Time frame
3 monthSponsors and contacts
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Source ClinicalTrials.gov