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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03220529
• Other study ID #: 2015P002404
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: September 2020

Study information

• Verified date: July 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: September 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratectasia
• Keratoconus
• Pellucid Marginal Corneal Degeneration

Intervention

Device:
• Brillouin Ocular Scanner

Locations

Country	Name	City	State
Switzerland	Institute for Refractive and Ophthalmic Surgery	Zurich
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Massachusetts Eye and Ear Infirmary

Countries where clinical trial is conducted

United States,  Switzerland, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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