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| Name | Class |
|---|---|
| Harvard Medical School (HMS and HSDM) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | Volunteers with normal corneas |
| |
| Patients with keratoconus | Patients diagnosed with keratoconus |
| |
| post-LASIK no complications | Subjects who underwent LASIK refractive surgery with no complications |
| |
| post-LASIK who developed ectasia | patients who underwent LASIK refractive surgery and developed ectasia as a complications |
| |
| 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. |
| |
| Volunteers to receive LASIK Surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brillouin imaging | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Elastic Modulus of the Cornea | Patients will be measured one time only at their imaging session | 2012-2022 |
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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
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General population
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatima Clouser, MS | Contact | 4077331679 | fclouser@mgh.harvard.edu | |
| Andy Yun, PhD | Contact | syun@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| Andy Yun, PhD | Masachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23361513 | Background | 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. | |
| 22513631 | Background | Scarcelli 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 23, 2019 | Jul 30, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| D004108 | Dilatation, Pathologic |
| D005642 | Fuchs' Endothelial Dystrophy |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
|
| 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. |
|
| 22159012 | Background | Scarcelli 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. |
| 19812712 | Background | Scarcelli 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. |
| D003317 | Corneal Dystrophies, Hereditary |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |