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| Name | Class |
|---|---|
| Massachusetts Eye and Ear Infirmary | OTHER |
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The purpose of this research study is to find out if the new Brillouin Ocular Scanner can measure the variation (difference) of the corneal elastic changes involved in the onset of corneal ectasia, induced by LASIK surgery and cornea collagen crosslinking (CXL) treatment. Ectasia refers to the thinning and bulging of the cornea and results in severe vision degradation (loss), which may occur because of a progressive disease (keratoconus) or because of LASIK surgery. It is believed that the structural weakening of the cornea plays a major role in developing ectasia. CXL is a treatment that is able to halt the progression of ectasia.
The Brillouin Ocular Scanner is a technique based on the principles used in the laser speed measuring of a car (radar gun). When laser light illuminates a moving sample, a portion of the light slightly changes color. In our body, e.g in eye and corneal tissue, very weak sound waves are naturally present and they can induce a similar color shift. Measuring this color shift with a sensitive light color meter (spectrometer), we will measure the sound speed in the tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal healthy subjects | Active Comparator | Healthy subjects with normal appearing corneas respecting all the general inclusion/exclusion criteria. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out. |
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| Keratoconus subjects | Active Comparator | Subjects classified as patients with mild, moderate, or advanced keratoconus. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out. |
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| Subjects diagnosed with PMD | Active Comparator | Subjects with Pellucid marginal corneal degeneration (PMD). Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out. |
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| Patients before and after LASK surgery | Active Comparator | Healthy subjects who are scheduled to undergo LASIK surgery. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out. |
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| Patients with keratoconus before and after CXL | Active Comparator | Subjects who are scheduled to undergo collagen crosslinking treatment. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brillouin Ocular Scanner | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brillouin frequency shift of corneal stroma | Brillouin frequency shift of corneal stroma in normal corneas and corneas diagnosed with keratoconus and pellucid marginal degeneration | at time of measurement |
| Change of Brillouin frequency shift from base line in corneas received LASIK surgery | Brillouin frequency shift in corneas before and after receiving LASIK surgery | 1 day and 4-8 weeks |
| Change of Brillouin frequency shift from base line in corneas received crosslinking treatment | Brillouin frequency shift in corneas before and after receiving crosslinking surgery | 3 days, 1 month, 3 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seok Hyun Yun, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States | ||
| Institute for Refractive and Ophthalmic Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25611213 | Background | Scarcelli G, Besner S, Pineda R, Kalout P, Yun SH. In vivo biomechanical mapping of normal and keratoconus corneas. JAMA Ophthalmol. 2015 Apr;133(4):480-2. doi: 10.1001/jamaophthalmol.2014.5641. No abstract available. | |
| 24938517 | Background | Scarcelli G, Besner S, Pineda R, Yun SH. Biomechanical characterization of keratoconus corneas ex vivo with Brillouin microscopy. Invest Ophthalmol Vis Sci. 2014 Jun 17;55(7):4490-5. doi: 10.1167/iovs.14-14450. |
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|
| Zurich |
| Switzerland |
| 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. |
| 26436482 | Background | Scarcelli G, Polacheck WJ, Nia HT, Patel K, Grodzinsky AJ, Kamm RD, Yun SH. Noncontact three-dimensional mapping of intracellular hydromechanical properties by Brillouin microscopy. Nat Methods. 2015 Dec;12(12):1132-4. doi: 10.1038/nmeth.3616. Epub 2015 Oct 5. |
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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