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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02118922
• Other study ID #: 2012P002178
• Status: Recruiting
• Start date: June 2013
• Est. completion date: September 2026

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Fatima Clouser, MS
• Phone: 4077331679
• Email: fclouser[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

Group I includes healthy subjects with normal appearing corneas, normal topography and pachymetry. Group II includes patients diagnosed as having mild, moderate or advanced keratoconus by our ophthalmology expert on the basis of topography and pachymetry. Group III includes healthy subjects who have undergone LASIK surgery in the past 12 months without complications. Inclusion criteria include normal post-operative topography and pachymetry. Group IV includes patients (age 20 - 60) who have undergone LASIK surgery at least 12 months before the study imaging and have been diagnosed with post-LASIK ectasia based on topography, pachymetry and clinical evaluation.Patients diagnosed with keratoconus. Group V- 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. Group VI-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. Group VII- 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.

Overall Exclusion Criteria for all groups: Volunteers who

• Have occludable narrow angles (without a patent peripheral iridotomy)

• Monocular subjects

• Do not or cannot understand the instructions for the imaging

Related Conditions & MeSH terms

• Crosslinking
• Ectasia
• Fuchs' Endothelial Dystrophy
• Keratoconus

Intervention

Procedure:
• Brillouin imaging

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Harvard Medical School (HMS and HSDM)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Scarcelli G, Kling S, Quijano E, Pineda R, Marcos S, Yun SH. Brillouin microscopy of collagen crosslinking: noncontact depth-dependent analysis of corneal elastic modulus. Invest Ophthalmol Vis Sci. 2013 Feb 19;54(2):1418-25. doi: 10.1167/iovs.12-11387. — 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, Yun SH. Confocal Brillouin microscopy for three-dimensional mechanical imaging. Nat Photonics. 2007 Dec 9;2:39-43. doi: 10.1038/nphoton.2007.250. — View Citation

Scarcelli G, Yun SH. In vivo Brillouin optical microscopy of the human eye. Opt Express. 2012 Apr 9;20(8):9197-202. doi: 10.1364/OE.20.009197. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elastic Modulus of the Cornea	Patients will be measured one time only at their imaging session	2012-2022