Corneal Elastography and Patient Specific Modeling

NCT03030755 | Recruiting

• 1 other identifier: 13-213
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Optical coherence tomography OTHER

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with refractive error who present for screening for refractive surgery and individuals with keratoconus who are evaluatedat the Cole Eye Institute in Cleveland, Ohio

You may qualify if:

• 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.

You may not qualify if:

• Inability to provide informed consent, including non-English speaking (if interpreter not available) and cognitively/mentally impaired (if legal guardian not available).

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation Cole Eye Institute

Cleveland, Ohio, 44195, United States

RECRUITING

Related 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.

  PMID: 21280911 BACKGROUND

• 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.

  PMID: 22039252 BACKGROUND

MeSH Terms

Conditions

Corneal Diseases; Dilatation, Pathologic; Refractive Errors; Keratoconus

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Eye Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• William Dupps, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Hoffman, MS

CONTACT

216-445-5248; moorehp@ccf.org

Rachel Rusnak

CONTACT

216-445-1256; rusnakr@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 25, 2017
• Study Start: May 1, 2016
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)