A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT02118922
Status
Recruiting
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Conditions

  • Crosslinking
  • Ectasia
  • Fuchs' Endothelial Dystrophy
  • Keratoconus

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Brillouin imaging — PROCEDURE

Study Details

We have developed novel Brillouin microscopy and we are testing its potential for keratoconus and ectasia diagnostics. We plan to perform axial scans of the cornea in human volunteers in order to compare biomechanical properties of Keratoconus vs. Normal corneas and compare biomechanical properties of post-LASIK ectasia vs. normal corneas.

Key Dates

Start date
Jun 30, 2013
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
168 participants (estimated)

Arms

  • Arm: Healthy volunteers
    Volunteers with normal corneas
  • Arm: Patients with keratoconus
    Patients diagnosed with keratoconus
  • Arm: post-LASIK no complications
    Subjects who underwent LASIK refractive surgery with no complications
  • Arm: post-LASIK who developed ectasia
    patients who underwent LASIK refractive surgery and developed ectasia as a complications
  • Arm: Volunteers to receive PRK surgery
    This group includes patients who have been diagnosed with myopia and have been scheduled to undergo PRK surgery. Patients with high astigmatism \> 2 diopter, prior ocular surgeries, and those patients taking any ocular medications except seasonal allergy medicine such as ketotifen or artificial tears will be excluded.
  • Arm: Volunteers to receive LASIK Surgery
    This group includes myopic patients who are scheduled to receive LASIK surgery. Patients with high astigmatism \> 2 diopter, prior ocular surgeries, and those patients taking any ocular medications except seasonal allergy medicine such as ketotifen and artificial tears will be excluded.
  • Arm: Patients with Fuch's Endothelial Corneal Dystrophy
    This group includes subjects who are diagnosed with Fuch's corneal dystrophy, at early, mild and advanced stages. The inclusion also extends to subjects with, and without keratoconus. But this exclude patients with any other corneal disorders other than keratoconus, and/or history of ophthalmological surgeries that may affect endothelium cell status, e.g. cataract surgeries.

Primary Outcome Measure

Elastic Modulus of the Cornea [ Time Frame: 2012-2022 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
giuliano scarcelli, PhD
[email protected]
617-768-8698
giuliano scarcelli, PhD (SUB_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MA

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