Corneal Biomechanical Analysis Using Brillouin Microscopy

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT04598932
Status
Enrolling By Invitation

Conditions

  • Keratoconus
  • Keratoconus, Stable
  • Keratoconus, Unstable

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Brillouin microscopy — DEVICE
    The Brillouin clinical instrument is comprised of three parts: a human interface, a laser-scanning confocal microscope, and an etalon-based spectrometer. The human interface is a modified ophthalmic slit-lamp instrument with chin support and headrest. The light source is a single longitudinal mode CW laser at 780 nm. A polarizing beam splitter and quarter-wave plate assembly sends the laser beam to the human interface. To focus light into the eye, a long-working distance microscope objective is used. Brillouin scattered light from the eye is collected with a single-mode optical fiber. For spectral analysis, a two-stage VIPA-etalon spectrometer configured with the cross-axis cascade principle and the spectrum is measured on a EM-CCD camera.

Study Details

The objective of this study is to measure the Brillouin biomechanical properties in keratoconic corneas and characterize biomechanical alterations that occur after corneal procedures that inherently strengthen or weaken the cornea by evaluating the change in Brillouin metrics before and after treatments.

Key Dates

Start date
Jun 1, 2021
Status verified
Sep 2025
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
220 participants (estimated)

Arms

  • Arm: 1: Normal Controls
    Patients with normal corneas without any prior surgery to serve as the control group
  • Arm: 2 Keratoconus
    Patients with various stages of keratoconus
  • Arm: 3: LASIK
    Patients with normal corneas who are undergoing laser in situ keratomileusis (LASIK)
  • Arm: Group 4: PRK
    Patients with normal corneas who are undergoing photorefractive keratectomy (PRK)
  • Arm: 5: SMILE
    Patients with normal corneas who are undergoing small incision lenticular extraction (SMILE)
  • Arm: 6: CXL
    Patients with keratoconus who are undergoing corneal cross-linking (CXL)

Primary Outcome Measure

Change in Brillouin Metrics [ Time Frame: Difference between baseline and 3 months after intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Cole Eye InstituteClevelandOhio44195-

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By research site
Cleveland Clinic Cole Eye Institute· Cleveland, OH

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