Keratoconus
Conditions
Keywords
Keratoconus progression, Vitamins and keratoconus, Vitamin supplementation
Brief summary
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.
Interventions
OTHERAntioxidants (Vitamins A,C,E) plus GSH
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).
OTHERPlacebo
Placebo pill
DIETARY_SUPPLEMENTCentrum
Centrum
COMBINATION_PRODUCTDietary Sources
From dietary sources of vitamins.
Sponsors
Fight for Sight
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Participants would be without illness or condition that could make follow-up, or compliance with study medication difficult. * Participants may have a prior diagnosis of Keratoconus, or may be diagnosed at the initial visit. * Participants should not have an eye diagnosis, other than Keratoconus, that could adversely influence the visual acuity. * These participants must not have had prior surgical procedure to treat Keratoconus, including collagen cross-linking, Intacs ring segments, or corneal transplantation.
Exclusion criteria
* would exclude smokers and former-smokers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Visual Acuity Measured by Snellen Chart | Baseline to 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma level of Vitamin A | Baseline to 24 months | Blood draws to look at plasma level of Vitamin A |
| Plasma level of Vitamin C | Baseline to 24 months | Blood draws to look at plasma level of Vitamin C |
| Change in cornea thickness as measured by video keratography | Baseline to 24 months | — |
| Plasma level of Vitamin E | Baseline to 24 months | Blood draws to look at plasma level of Vitamin E |
| Plasma level of Glutathione (GSH) | Baseline to 24 months | Blood draws to look at plasma level of GSH |
Countries
United States
Outcome results
None listed