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

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ClinicalTrials.gov Identifier: NCT02118922
Recruitment Status : Unknown
Verified April 2014 by Seok Hyun Yun, Massachusetts General Hospital.
Recruitment status was:  Recruiting
First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Sponsor:
Collaborator:
Harvard Medical School
Information provided by (Responsible Party):
Seok Hyun Yun, Massachusetts General Hospital

Brief 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. Normal corneas and compare biomechanical properties of post-LASIK ectasia vs. normal corneas.

Condition or disease Intervention/treatment
Keratoconus Ectasia Crosslinking Procedure: Brillouin imaging

Study Type : Observational
Estimated Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Study Start Date : June 2013
Estimated Primary Completion Date : February 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy volunteers
Volunteers with normal corneas
Procedure: Brillouin imaging
Patients with keratoconus
Patients diagnosed with keratoconus
Procedure: Brillouin imaging
post-LASIK no complications
Subjects who underwent LASIK refractive surgery with no complications
Procedure: Brillouin imaging
post-LASIK who developed ectasia
patients who underwent LASIK refractive surgery and developed ectasia as a complications
Procedure: Brillouin imaging



Primary Outcome Measures :
  1. Elastic Modulus of the Cornea [ Time Frame: Patients will be measured one time only at their imaging session ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
General population
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.

Exclusion Criteria: Volunteers who

  • Have occludable narrow angles (without a patent peripheral iridotomy)
  • Monocular subjects
  • Do not or cannot understand the instructions for the imaging

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118922


Contacts
Contact: giuliano scarcelli 6177688698 scarcelli.giuliano@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: giuliano scarcelli, PhD    617-768-8698    scarcelli.giuliano@mgh.harvard.edu   
Sub-Investigator: giuliano scarcelli, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Harvard Medical School