Actively Recruiting

Age: 20Years - 75Years
All Genders
Healthy Volunteers
ID02118922

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

Led by Massachusetts General Hospital · Updated on 2025-11-06

168

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

H

Harvard Medical School (HMS and HSDM)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the potential of a new technique called Brillouin microscopy to diagnose corneal conditions such as keratoconus and ectasia. The study compares the biomechanical properties of corneas in people with keratoconus, those with post-LASIK ectasia, and individuals with normal corneas. This observational study aims to better understand differences in corneal tissue using this advanced imaging method. Participants include volunteers with normal corneas, patients diagnosed with various stages of keratoconus, individuals who had LASIK surgery with or without complications, people scheduled for PRK or LASIK surgery, and patients with Fuch's endothelial corneal dystrophy. The study involves axial scans of the cornea using Brillouin imaging to assess and compare corneal biomechanics across these groups. Specific inclusion and exclusion criteria apply to each group based on diagnosis, prior surgeries, and other eye health factors. During the study, participants undergo corneal imaging to measure the cornea's elastic modulus, reflecting its biomechanical properties. Researchers monitor these properties over time to evaluate the diagnostic capabilities of Brillouin microscopy. Participants will be assessed for corneal health through topography, pachymetry, and clinical evaluations, with the study lasting several years to gather comprehensive data. The research team also excludes individuals unable to understand imaging instructions or with certain eye conditions to ensure accurate measurements.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 20 to 75 years
  • Healthy subjects with normal corneas, normal topography, and pachymetry
  • Patients diagnosed with mild, moderate, or advanced keratoconus based on expert evaluation
  • Healthy subjects who had LASIK surgery in the past 12 months without complications, with normal post-operative topography and pachymetry
  • Patients aged 20 to 60 diagnosed with post-LASIK ectasia at least 12 months after surgery based on clinical evaluation
  • Patients diagnosed with myopia scheduled for PRK surgery, excluding those with high astigmatism > 2 diopters or prior ocular surgeries
  • Patients diagnosed with myopia scheduled for LASIK surgery, excluding those with high astigmatism > 2 diopters or prior ocular surgeries
  • Patients diagnosed with Fuch's endothelial corneal dystrophy at early, mild, or advanced stages, including those with or without keratoconus, excluding other corneal disorders or history of surgeries affecting endothelial cells
Not Eligible

You will not qualify if you...

  • Volunteers with occludable narrow angles without a patent peripheral iridotomy
  • Monocular subjects
  • Individuals who do not or cannot understand instructions for the imaging
  • Patients with high astigmatism greater than 2 diopters in PRK or LASIK groups
  • Patients with prior ocular surgeries other than specified LASIK or PRK
  • Patients taking ocular medications other than seasonal allergy medicines such as ketotifen or artificial tears
  • Patients with corneal disorders other than keratoconus or Fuch's dystrophy or history of surgeries affecting corneal endothelium, such as cataract surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 day

Participants undergo Brillouin imaging to assess the corneal properties related to ectasia and other corneal conditions.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 10 years

Participants may be observed over time to monitor changes in corneal properties and disease progression.

Follow-up visits as scheduled depending on participant group

Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

F

Fatima Clouser, MS

A

Andy Yun, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

7

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Frequently Asked Questions

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Published Research Related To This Trial

Brillouin microscopy of collagen crosslinking: noncontact depth-dependent analysis of corneal elastic modulus.

Giuliano Scarcelli, Sabine Kling, Elena Quijano...

https://pubmed.ncbi.nlm.nih.gov/23361513