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Trial record 30 of 117 for:    cornea AND cross-linking

A Study to Test the Potential of Brillouin Microscopy for Biomechanical Properties Measurements in Human Cornea

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ClinicalTrials.gov Identifier: NCT03220529
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : July 18, 2017
Sponsor:
Collaborator:
Massachusetts Eye and Ear Infirmary
Information provided by (Responsible Party):
Seok Hyun Yun, Massachusetts General Hospital

Brief Summary:

The purpose of this research study is to find out if the new Brillouin Ocular Scanner can measure the variation (difference) of the corneal elastic changes involved in the onset of corneal ectasia, induced by LASIK surgery and cornea collagen crosslinking (CXL) treatment. Ectasia refers to the thinning and bulging of the cornea and results in severe vision degradation (loss), which may occur because of a progressive disease (keratoconus) or because of LASIK surgery. It is believed that the structural weakening of the cornea plays a major role in developing ectasia. CXL is a treatment that is able to halt the progression of ectasia.

The Brillouin Ocular Scanner is a technique based on the principles used in the laser speed measuring of a car (radar gun). When laser light illuminates a moving sample, a portion of the light slightly changes color. In our body, e.g in eye and corneal tissue, very weak sound waves are naturally present and they can induce a similar color shift. Measuring this color shift with a sensitive light color meter (spectrometer), we will measure the sound speed in the tissue.


Condition or disease Intervention/treatment Phase
Pellucid Marginal Corneal Degeneration Keratoconus Keratectasia Device: Brillouin Ocular Scanner Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Study to Test the Potential of Brillouin Microscopy for Biomechanical Properties Measurements in Human Cornea
Actual Study Start Date : November 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Normal healthy subjects
Healthy subjects with normal appearing corneas respecting all the general inclusion/exclusion criteria. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.
Device: Brillouin Ocular Scanner
Active Comparator: Keratoconus subjects
Subjects classified as patients with mild, moderate, or advanced keratoconus. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.
Device: Brillouin Ocular Scanner
Active Comparator: Subjects diagnosed with PMD
Subjects with Pellucid marginal corneal degeneration (PMD). Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.
Device: Brillouin Ocular Scanner
Active Comparator: Patients before and after LASK surgery
Healthy subjects who are scheduled to undergo LASIK surgery. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.
Device: Brillouin Ocular Scanner
Active Comparator: Patients with keratoconus before and after CXL
Subjects who are scheduled to undergo collagen crosslinking treatment. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.
Device: Brillouin Ocular Scanner



Primary Outcome Measures :
  1. Brillouin frequency shift of corneal stroma [ Time Frame: at time of measurement ]
    Brillouin frequency shift of corneal stroma in normal corneas and corneas diagnosed with keratoconus and pellucid marginal degeneration

  2. Change of Brillouin frequency shift from base line in corneas received LASIK surgery [ Time Frame: 1 day and 4-8 weeks ]
    Brillouin frequency shift in corneas before and after receiving LASIK surgery

  3. Change of Brillouin frequency shift from base line in corneas received crosslinking treatment [ Time Frame: 3 days, 1 month, 3 months, 6 months ]
    Brillouin frequency shift in corneas before and after receiving crosslinking surgery



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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects with healthy cornea
  • Patients with mild, moderate, or advanced keratoconus
  • Subjects diagnosed with PMD
  • Patients before and after LASK surgery
  • Patients with keratoconus before and after collagen crosslinking treatment

Exclusion Criteria:

  • Normal volunteer group: presbyopia and/or cataract
  • Keratoconus subjects group: corneas with scars developed, received any ocular surgery, such as laser vision correction surgeries or CXL treatment
  • Subjects diagnosed with PMD: excludes corneas received any ocular surgery, such as laser vision correction or CXL treatment
  • Patients before and after LASK surgery Corneas received priori ocular surgeries, taking any ocular medications except season allergy medicine such as artificial tears

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220529


Contacts
Contact: Peng Shao, PhD (01) 617 643 5808 pshao1@mgh.harvard.edu
Contact: Seok Hyun Yun, PhD (01) 617 768 8704 syun@hms.harvard.edu

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Peng Shao         
Switzerland
Institute for Refractive and Ophthalmic Surgery Recruiting
Zurich, Switzerland
Contact: Claudia Kindler    41 43 488 38 00      
Sponsors and Collaborators
Massachusetts General Hospital
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Seok Hyun Yun, PhD Massachusetts General Hospital