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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Apr 17, 2014

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Lasik

ClinConnect Summary

This clinical trial is looking at a new technology called Brillouin microscopy to see how well it can help diagnose conditions related to the cornea, such as keratoconus and ectasia. The researchers want to understand the differences in the mechanical properties of the cornea between healthy individuals and those with these conditions. They will perform scans on the cornea of volunteers to gather this information.

To participate, you may be eligible if you are a healthy adult with normal corneas or if you have been diagnosed with keratoconus or post-LASIK ectasia. The study includes a variety of groups, such as those scheduled for LASIK or PRK surgeries and patients with Fuchs' endothelial dystrophy. Participants will undergo painless imaging of their eyes, and the study is currently recruiting volunteers of all genders, aged 20 to 60. It's important to know that certain health conditions or previous eye surgeries may prevent some people from joining the trial.

Gender

ALL

Eligibility 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

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Andy Yun, PhD

Principal Investigator

Masachusetts General Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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