Actively Recruiting

Age: 16Years - 80Years
All Genders
Healthy Volunteers
ID03030755

Corneal Elastography and Patient Specific Modeling for Keratoconus and Refractive Surgery Candidates

Led by The Cleveland Clinic · Updated on 2026-06-03

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying corneal biomechanical properties to better understand and predict individual responses to corneal treatments. This observational study focuses on patients with keratoconus being evaluated for corneal crosslinking and patients with refractive errors being considered for refractive surgery such as LASIK. The goal is to develop tools and simulations that characterize corneal strength and help identify risk factors for corneal ectasia, a serious cause of vision problems worldwide. Participants will undergo imaging using an optical coherence tomography (OCT) system to assess the mechanical condition of their corneas. Computational models of each eye will be created from these images, and simulations of the planned treatments will be performed to predict how the cornea will change shape. No additional procedures beyond imaging are involved in this study. During the study, participants will have their eyes imaged and data collected to compare predicted corneal responses with actual treatment outcomes. Researchers will evaluate the accuracy of these computational models three months after surgery. The total participation time varies, and safety monitoring includes ensuring informed consent and understanding participant eligibility. The study is open to a broad age range of adults and includes those planning to undergo corneal treatments or surgery.

CONDITIONS

Brief Title

Corneal Elastography and Patient Specific Modeling

Who Can Participate

Age: 16Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Any patient with keratoconus diagnosed by standard criteria, including topographic steepness and irregular astigmatism consistent with keratoconus
  • Any patient deemed a candidate for LASIK laser vision correction and scheduled for surgery
  • Age between 16 and 80 years
  • Ability to provide informed consent and communicate in English or have an interpreter available
Not Eligible

You will not qualify if you...

  • Inability to provide informed consent, including non-English speaking without an available interpreter
  • Cognitive or mental impairment without a legal guardian available

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single assessment

Participants undergo imaging using an optical coherence tomography (OCT)-based system to characterize corneal biomechanical properties and build computational models of the eye.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 3 months

Participants are observed over time to compare simulated interventions from computational models with actual treatment outcomes.

Follow-up visits as scheduled depending on treatment outcomes

Trial Site Locations

Total: 1 location

1

Cleveland Clinic Foundation Cole Eye Institute

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

P

Pamela Hoffman, MS

R

Rachel Rusnak

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Frequently Asked Questions

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