NCT03220529

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

2.8 years

First QC Date

June 9, 2017

Last Update Submit

July 29, 2022

Conditions

Pellucid Marginal Corneal DegenerationKeratoconusKeratectasia

Outcome Measures

Primary Outcomes (3)

  • Brillouin frequency shift of corneal stroma

    Brillouin frequency shift of corneal stroma in normal corneas and corneas diagnosed with keratoconus and pellucid marginal degeneration

    at time of measurement

  • Change of Brillouin frequency shift from base line in corneas received LASIK surgery

    Brillouin frequency shift in corneas before and after receiving LASIK surgery

    1 day and 4-8 weeks

  • Change of Brillouin frequency shift from base line in corneas received crosslinking treatment

    Brillouin frequency shift in corneas before and after receiving crosslinking surgery

    3 days, 1 month, 3 months, 6 months

Study Arms (5)

Normal healthy subjects

ACTIVE COMPARATOR

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

Keratoconus subjects

ACTIVE COMPARATOR

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

Subjects diagnosed with PMD

ACTIVE COMPARATOR

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

Patients before and after LASK surgery

ACTIVE COMPARATOR

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

Patients with keratoconus before and after CXL

ACTIVE COMPARATOR

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

Interventions

Brillouin Ocular ScannerDEVICE
Keratoconus subjectsNormal healthy subjectsPatients before and after LASK surgeryPatients with keratoconus before and after CXLSubjects diagnosed with PMD

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Institute for Refractive and Ophthalmic Surgery

Zurich, Switzerland

Location

Related Publications (4)

  • 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.

    PMID: 25611213BACKGROUND

  • 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.

    PMID: 24938517BACKGROUND

  • 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.

    PMID: 22159012BACKGROUND

  • 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.

    PMID: 26436482BACKGROUND

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Seok Hyun Yun, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 9, 2017

First Posted

July 18, 2017

Study Start

November 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

August 2, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)CH(1)