Corneal Elastography and Patient Specific Modeling

Keratoconus Clinical Trial

Official title:

Corneal Elastography and Patient Specific Modeling

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03030755
• Other study ID #: 13-213
• Status: Recruiting
• Start date: May 2016
• Est. completion date: May 2024

Study information

• Verified date: January 2023
• Source: The Cleveland Clinic
• Contact: Pamela Hoffman, MS
• Phone: 216-445-5248
• Email: moorehp[@]ccf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cornea; Ectasia
• Keratoconus
• Refractive Errors

Intervention

Other:
• Optical coherence tomography

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation Cole Eye Institute	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 month