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Not enough participant interest.
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| Name | Class |
|---|---|
| Fight for Sight | OTHER |
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Keratoconus is the most common primary cornea ectasia, where the cornea undergoes structural changes, leading to loss of tissue integrity and vision loss. The prevalence of Keratoconus is 1:2000 in the general population. Oxidative stress has been thought to have a major effect in the disease pathogenesis of Keratoconus. In vitro studies have shown increase in metabolites related to oxidative stress in Keratoconus disease, and that Keratoconus cells undergo increased oxidative stress and tissue damage. Animal models have shown a therapeutic effect of Vitamin C (ascorbate) in corneal wound healing. Glutathione and Vitamins A, C, and E are important antioxidants in the human body. To this date, the role of systemic antioxidant supplementation in Keratoconus patients has yet to be studied. In addition, it has yet to be established as to whether there is a correlation between serum antioxidant levels, and the severity of disease in the Keratoconus patient. The investigators propose to investigate the plasma levels of antioxidants in relation to disease severity. The investigators will also investigate the role of antioxidant supplementation-consisting of parenteral Glutathione (GSH), and Vitamins A, C and E-in delaying the disease progression in Keratoconus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo with Dietary Sources of Vitamins | Placebo Comparator | Persons assigned to placebo, who obtain Vitamins A, C, E and Glutathione from dietary sources alone, and have not been on oral RDA supplementation, in the 1 month leading up the time of enrollment and throughout the study period. |
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| Antioxidants(Vitamins A,C,E) plus GSH, plus Centrum | Active Comparator | Persons assigned to the study medication, and are continuing the take an oral RDA supplementation, in the form of Centrum. |
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| Antioxidants (Vitamins A,C, E) plus GSH | Active Comparator | Persons assigned to the study medication alone, without oral RDA supplementation in the 1 month leading up the time of enrollment and throughout the study period. |
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| Placebo plus Centrum | Active Comparator | Persons assigned to placebo, who have been on oral RDA supplementation, who would continue to do so throughout the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antioxidants (Vitamins A,C,E) plus GSH | Other | Study medication would contain 500 milligrams of vitamin C, 400 International Units of vitamin E, and 15 milligrams of beta-carotene (the equivalent to 25,000 International Units of vitamin A).The study medication would also contain 1000mg of Glutathione (GSH). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Acuity Measured by Snellen Chart | Baseline to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cornea thickness as measured by video keratography | Baseline to 24 months | |
| Plasma level of Vitamin A | Blood draws to look at plasma level of Vitamin A | Baseline to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Koo, M.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Institute-- Palm Beach Gardens | Palm Beach Gardens | Florida | 33418 | United States |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000975 | Antioxidants |
| ID | Term |
|---|---|
| D001685 | Biological Factors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Placebo | Other | Placebo pill |
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| Centrum | Dietary Supplement | Centrum |
|
| Dietary Sources | Combination Product | From dietary sources of vitamins. |
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| Plasma level of Vitamin C | Blood draws to look at plasma level of Vitamin C | Baseline to 24 months |
| Plasma level of Vitamin E | Blood draws to look at plasma level of Vitamin E | Baseline to 24 months |
| Plasma level of Glutathione (GSH) | Blood draws to look at plasma level of GSH | Baseline to 24 months |
| D020011 | Protective Agents |
| D045505 | Physiological Effects of Drugs |
| D020313 | Specialty Uses of Chemicals |