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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

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.

Condition or disease Intervention/treatment
Cornea; Ectasia Refractive Errors Keratoconus Other: Optical coherence tomography

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Corneal Elastography and Patient Specific Modeling
Study Start Date : May 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03030755

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Contact: Pamela Hoffman, MS 216-445-5248
Contact: Rachel Rusnak 216-445-1256

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United States, Ohio
Cleveland Clinic Foundation Cole Eye Institute Recruiting
Cleveland, Ohio, United States, 44195
Contact: Pamela Hoffman, MS    216-445-5248   
Sponsors and Collaborators
The Cleveland Clinic
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Principal Investigator: William Dupps, MD The Cleveland Clinic
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Responsible Party: William Dupps Jr., MD, Staff Physician, The Cleveland Clinic Identifier: NCT03030755    
Other Study ID Numbers: 13-213
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Refractive Errors
Corneal Diseases
Eye Diseases