Clinical trial NCT03030755: Corneal Elastography and Patient Specific Modeling
Official title: Corneal Elastography and Patient Specific Modeling
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cornea; Ectasia
Refractive Errors
Keratoconus
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Predictive accuracy of computational models in corneal surgery
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation Cole Eye Institute
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: William Dupps, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ford MR, Dupps WJ Jr, Rollins AM, Sinha RA, Hu Z. Method for optical coherence elastography of the cornea. J Biomed Opt. 2011 Jan-Feb;16(1):016005. doi: 10.1117/1.3526701.
citation: Sinha Roy A, Dupps WJ Jr. Patient-specific computational modeling of keratoconus progression and differential responses to collagen cross-linking. Invest Ophthalmol Vis Sci. 2011 Nov 25;52(12):9174-87. doi: 10.1167/iovs.11-7395.