KeratoconusNCT02118922
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
An observational study of Keratoconus and Ectasia, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconus, Ectasia, Crosslinking
- What is being tested?
- Brillouin imaging
- Type of treatment
- Surgery or procedure
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Sep 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andy Yun, PhD contact
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
giuliano scarcelli, PhD, 6177688698, scarcelli.giuliano@mgh.harvard.edu
giuliano scarcelli, PhD
About this study
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.
- Conditions
- Keratoconus, Ectasia, Crosslinking, Fuchs' Endothelial Dystrophy
- Being tested
- Brillouin imaging
- Keywords
- LASIK
- Medical subject headings
- Keratoconus, Dilatation, Pathologic, Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brillouin imagingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Volunteers with normal corneas Receives: Procedure: Brillouin imaging | |
| Patients with keratoconus | Patients diagnosed with keratoconus Receives: Procedure: Brillouin imaging | |
| post-LASIK no complications | Subjects who underwent LASIK refractive surgery with no complications Receives: Procedure: Brillouin imaging | |
| post-LASIK who developed ectasia | patients who underwent LASIK refractive surgery and developed ectasia as a complications Receives: Procedure: 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. Receives: Procedure: 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. Receives: Procedure: 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. Receives: Procedure: Brillouin imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elastic Modulus of the Cornea
Patients will be measured one time only at their imaging session
Measured: 2012-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJun 2013
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Seok Hyun Yun, Massachusetts General Hospital
- Investigators
- Andy Yun, PhD, Principal investigator, Masachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118922
- Sponsor's protocol ID
- 2012P002178
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2014
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23361513Scarcelli 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.
PubMed 22513631Scarcelli 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.
PubMed 22159012Scarcelli 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.
PubMed 19812712