Recruiting

Observational Study

Sponsor:

The Cleveland Clinic

Code:

NCT03030755

Conditions

Cornea; Ectasia

Refractive Errors

Keratoconus

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Accepted

Interventions

Optical coherence tomography

Study Details

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.

Conditions

Cornea; Ectasia

Refractive Errors

Keratoconus

Study ID

NCT03030755

Start date

May, 2016

Status verified date

Jun, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Accepted

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

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Interventions

Optical coherence tomography

Primary outcome measure

  • Predictive accuracy of computational models in corneal surgery [ Time Frame: 3 month ]

Central Contacts and Locations

Central contacts

Pamela Hoffman, MS

216-445-5248moorehp@ccf.org

Rachel Rusnak

216-445-1256rusnakr@ccf.org

Locations

Cleveland Clinic Foundation Cole Eye Institute

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Pamela Hoffman, MS

216-445-5248moorehp@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-06-03.