Taking people in United StatesNo phase

Brillouin microscope imaging to detect keratoconus and corneal ectasia

Tests a new eye scan of corneal stiffness in people with keratoconus or ectasia.

Key facts

Who runs it: Massachusetts General Hospital
Where: Boston, United StatesSee the site
Trial code: NCT02118922
Registry title: A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Status: Recruiting
People taking part: 168 people, planned
Started: Jun 2013
Expected to end: Sept 2030
Type of study: Observational, 7 groups
Treatments tested: Brillouin imaging
Record updated: 8 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with healthy corneas, keratoconus, ectasia after LASIK, or Fuchs' corneal dystrophy, and people about to have LASIK or PRK. It tests a new imaging method of the cornea.

Age: 20 to 75 years. The group with ectasia after LASIK is 20 to 60 years.
Sex: All sexes can join.
Disease stage: Groups: healthy corneas; mild, moderate or advanced keratoconus; LASIK in the past 12 months without problems; ectasia (thinning and bulging of the cornea) at least 12 months after LASIK; short-sightedness with planned PRK or LASIK; Fuchs' corneal dystrophy at early, mild or advanced stage.
Earlier treatment: PRK and LASIK groups cannot have had earlier eye surgery. They cannot use eye medicines except seasonal allergy drops such as ketotifen or artificial tears. The Fuchs' group cannot have had eye surgery that may affect the inner cornea cells, such as cataract surgery.

Main reasons for not taking part

Narrow eye drainage angles that may close, without an open laser hole in the iris (patent peripheral iridotomy)
Having sight in only one eye
Not able to understand the imaging instructions
PRK and LASIK groups: astigmatism over 2 diopter
Fuchs' group: any other cornea disorder besides keratoconus

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 20 and 75 years old?

Where in United States

Massachusetts General HospitalBoston, United StatesContact: giuliano scarcelli, PhDTaking people

About the trial

What the trial wants to find out

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.

The 7 groups in the trial

Healthy volunteers
Volunteers with normal corneas
Treatment: Brillouin imaging
Patients with keratoconus
Patients diagnosed with keratoconus
Treatment: Brillouin imaging
post-LASIK no complications
Subjects who underwent LASIK refractive surgery with no complications
Treatment: Brillouin imaging
post-LASIK who developed ectasia
patients who underwent LASIK refractive surgery and developed ectasia as a complications
Treatment: Brillouin imaging
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.
Treatment: Brillouin imaging
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.
Treatment: Brillouin imaging
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.
Treatment: Brillouin imaging