The Role of Antioxidant Supplementation in Keratoconus Patients

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Keratoconus

In brief

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.

Key facts

Study ID

NCT02827747

Run by

University of Miami

People needed

0

Starts

2021-08-01

Expected to finish

2023-03-01

Last updated by the study team

2021-08-16

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• would exclude smokers and former-smokers.

Where it is running

• Bascom Palmer Eye Institute-- Palm Beach Gardens — Palm Beach Gardens, Florida, United States

Full record on ClinicalTrials.gov

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