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NCT Number: NCT03030755

Corneal Elastography and Patient Specific Modeling

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.

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Key information

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Foundation Cole Eye Institute

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Pamela Hoffman, MS

CONTACT

[email protected]

216-445-5248

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

optical coherence tomography

Other

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Pamela Hoffman, MS

CONTACT

[email protected]

216-445-5248

Rachel Rusnak

CONTACT

[email protected]

216-445-1256

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Jan 25, 2017
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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