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Corneal Elastography and Patient Specific Modeling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03030755
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : February 25, 2020
Information provided by (Responsible Party):
William Dupps Jr., MD, The Cleveland Clinic

Tracking Information
First Submitted Date January 11, 2017
First Posted Date January 25, 2017
Last Update Posted Date February 25, 2020
Study Start Date May 2016
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2017)
Predictive accuracy of computational models in corneal surgery [ Time Frame: 3 month ]
Computational model predictions of corneal interventions will be compared to actual clinical outcomes for each enrolled subject
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Corneal Elastography and Patient Specific Modeling
Official Title Corneal Elastography and Patient Specific Modeling
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
  • Cornea; Ectasia
  • Refractive Errors
  • Keratoconus
Intervention Other: Optical coherence tomography
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 22, 2017)
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
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).
Sexes Eligible for Study: All
Ages 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contact: Pamela Hoffman, MS 216-445-5248
Contact: Rachel Rusnak 216-445-1256
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT03030755
Other Study ID Numbers 13-213
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party William Dupps Jr., MD, The Cleveland Clinic
Study Sponsor The Cleveland Clinic
Collaborators Not Provided
Principal Investigator: William Dupps, MD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date February 2020