Testing Brillouin Microscopy for Diagnosing Corneal Conditions
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
This study is testing a new imaging technique called Brillouin microscopy to see if it can better diagnose corneal issues like keratoconus and ectasia in people.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 168 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT02118922 on ClinicalTrials.gov |
What this trial studies
This study evaluates the diagnostic capabilities of Brillouin microscopy in assessing corneal conditions such as keratoconus and ectasia. It involves performing axial scans of the cornea on human volunteers to compare the biomechanical properties of keratoconus and normal corneas, as well as post-LASIK ectasia versus normal corneas. The study aims to enhance diagnostic accuracy for these conditions using advanced imaging techniques.
Who should consider this trial
Good fit: Ideal candidates include individuals with normal corneas, those diagnosed with varying degrees of keratoconus, and patients who have undergone LASIK surgery.
Not a fit: Patients with high astigmatism over 2 diopters, prior ocular surgeries, or those on ocular medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for corneal ectasia and keratoconus, allowing for better patient management.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for corneal diagnostics, but the specific application of Brillouin microscopy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Andy Yun, PhD — Masachusetts General Hospital
- Study coordinator: Fatima Clouser, MS
- Email: fclouser@mgh.harvard.edu
- Phone: 4077331679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.