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Study is testing the efficacy of treating corneal thinning conditions with Vitamin B2 (Riboflavin) and the application on UV Light.
Corneal thinning conditions, i.e. keratoconus or ectasia, weaken the cornea which then causes the front of the eye to bulge out. This results in distorted vision and could eventually result in the need for a cornea transplant. This study proposes to conclude that saturating the cornea with vitamin B2 (Riboflavin) and then applying 365nm wavelength of Ultra Violet Light will result in the various layers of corneal tissue linking together. This cross linking results in a stronger cornea which is designed to halt the progression of keratoconus or ectasia. This treatment is already being successfully used in Europe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cross linking treatment for corneal thinning | Experimental | Cornea will be saturated with Vitamin B2 (Riboflavin) and then treated with 365 nm wavelength ultra violet light. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riboflavin | Drug | Corneal cross linking achieved by combination of Riboflavin and ultraviolet light |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best Corrected Visual Acuity | Use a standard eye chart to determine changes in the subject's best Visual Acuity (with glasses or contact) performed by research staff | Baseline and 1 year |
| Change in Uncorrected Visual Acuity | Use a standard eye chart to determine changes in the subject's best Visual Acuity (without glasses or contact) performed by clinic technician | Baseline and 1 year |
| Occurrence of Adverse Events | Surgeon notes any occurrence of adverse events related to the treatment | Through study completion, an average of 1 year |
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Inclusion Criteria:
Contact Lens Type Minimum Discontinuation Time Soft 1 Week Soft Extended Wear 2 Weeks Soft Toric 3 Weeks Rigid Gas Permeable 2 Weeks per decade of wear
Exclusion Criteria:
Eyes classified as either normal or atypical normal on the severity grading scheme
Corneal pachymetry at the screening exam that is < 400 microns at the thinnest point in the eye(s) to be treated when the transepithelial (isotonic) riboflavin solution alone will be used or < 300 microns when the hypotonic riboflavin will be used.
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
Pregnancy (including plan to become pregnant) or lactation during the course of the study
A known sensitivity to study medications
Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tony F Sterrett | Contact | 702-932-4265 | tsterrett@wellish.com | |
| Kent L Wellish, MD | Contact | 702-339-2020 | klwellish@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kent L Wellish, MD | Wellish Vision Institute | Principal Investigator |
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Unidentifiable patient data and pre- and post-op results will be shared.
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D012256 | Riboflavin |
| D014466 | Ultraviolet Rays |
| ID | Term |
|---|---|
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D055620 | Optical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D011840 | Radiation, Nonionizing |
| D013472 | Sunlight |
| D014887 | Weather |
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |