search
Back to results

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

Primary Purpose

Pellucid Marginal Corneal Degeneration, Keratoconus, Keratectasia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Brillouin Ocular Scanner
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pellucid Marginal Corneal Degeneration

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts Eye and Ear Infirmary
  • Institute for Refractive and Ophthalmic Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Normal healthy subjects

Keratoconus subjects

Subjects diagnosed with PMD

Patients before and after LASK surgery

Patients with keratoconus before and after CXL

Arm Description

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.

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.

Subjects with Pellucid marginal corneal degeneration (PMD). Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.

Healthy subjects who are scheduled to undergo LASIK surgery. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.

Subjects who are scheduled to undergo collagen crosslinking treatment. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.

Outcomes

Primary Outcome Measures

Brillouin frequency shift of corneal stroma
Brillouin frequency shift of corneal stroma in normal corneas and corneas diagnosed with keratoconus and pellucid marginal degeneration
Change of Brillouin frequency shift from base line in corneas received LASIK surgery
Brillouin frequency shift in corneas before and after receiving LASIK surgery
Change of Brillouin frequency shift from base line in corneas received crosslinking treatment
Brillouin frequency shift in corneas before and after receiving crosslinking surgery

Secondary Outcome Measures

Full Information

First Posted
June 9, 2017
Last Updated
July 29, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Eye and Ear Infirmary
search

1. Study Identification

Unique Protocol Identification Number
NCT03220529
Brief Title
A Study to Test the Potential of Brillouin Microscopy for Biomechanical Properties Measurements in Human Cornea
Official Title
A Study to Test the Potential of Brillouin Microscopy for Biomechanical Properties Measurements in Human Cornea
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Eye and Ear Infirmary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pellucid Marginal Corneal Degeneration, Keratoconus, Keratectasia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal healthy subjects
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Keratoconus subjects
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Subjects diagnosed with PMD
Arm Type
Active Comparator
Arm Description
Subjects with Pellucid marginal corneal degeneration (PMD). Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.
Arm Title
Patients before and after LASK surgery
Arm Type
Active Comparator
Arm Description
Healthy subjects who are scheduled to undergo LASIK surgery. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.
Arm Title
Patients with keratoconus before and after CXL
Arm Type
Active Comparator
Arm Description
Subjects who are scheduled to undergo collagen crosslinking treatment. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.
Intervention Type
Device
Intervention Name(s)
Brillouin Ocular Scanner
Primary Outcome Measure Information:
Title
Brillouin frequency shift of corneal stroma
Description
Brillouin frequency shift of corneal stroma in normal corneas and corneas diagnosed with keratoconus and pellucid marginal degeneration
Time Frame
at time of measurement
Title
Change of Brillouin frequency shift from base line in corneas received LASIK surgery
Description
Brillouin frequency shift in corneas before and after receiving LASIK surgery
Time Frame
1 day and 4-8 weeks
Title
Change of Brillouin frequency shift from base line in corneas received crosslinking treatment
Description
Brillouin frequency shift in corneas before and after receiving crosslinking surgery
Time Frame
3 days, 1 month, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seok Hyun Yun, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Institute for Refractive and Ophthalmic Surgery
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25611213
Citation
Scarcelli G, Besner S, Pineda R, Kalout P, Yun SH. In vivo biomechanical mapping of normal and keratoconus corneas. JAMA Ophthalmol. 2015 Apr;133(4):480-2. doi: 10.1001/jamaophthalmol.2014.5641. No abstract available.
Results Reference
background
PubMed Identifier
24938517
Citation
Scarcelli G, Besner S, Pineda R, Yun SH. Biomechanical characterization of keratoconus corneas ex vivo with Brillouin microscopy. Invest Ophthalmol Vis Sci. 2014 Jun 17;55(7):4490-5. doi: 10.1167/iovs.14-14450.
Results Reference
background
PubMed Identifier
22159012
Citation
Scarcelli G, Pineda R, Yun SH. Brillouin optical microscopy for corneal biomechanics. Invest Ophthalmol Vis Sci. 2012 Jan 20;53(1):185-90. doi: 10.1167/iovs.11-8281.
Results Reference
background
PubMed Identifier
26436482
Citation
Scarcelli G, Polacheck WJ, Nia HT, Patel K, Grodzinsky AJ, Kamm RD, Yun SH. Noncontact three-dimensional mapping of intracellular hydromechanical properties by Brillouin microscopy. Nat Methods. 2015 Dec;12(12):1132-4. doi: 10.1038/nmeth.3616. Epub 2015 Oct 5.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs