Corneal Elastography and Patient Specific Modeling

Recruiting

• Conditions: Cornea; Ectasia; Refractive Errors; Keratoconus

• Registration Number: NCT03030755
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-05
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-22
• Study First Posted: 2017-01-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive accuracy of computational models in corneal surgery	3 month	Computational model predictions of corneal interventions will be compared to actual clinical outcomes for each enrolled subject

Trial Locations

Locations (1)

Cleveland Clinic Foundation Cole Eye Institute; 🇺🇸 Cleveland, Ohio, United States