The Role of Antioxidant Supplementation in Keratoconus Patients

University of Miami

Status and phase: Withdrawn; Phase 2

Conditions: Keratoconus

Treatments: Combination Product: Dietary Sources; Dietary Supplement: Centrum; Other: Antioxidants (Vitamins A,C,E) plus GSH; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02827747

20150646

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups, including a placebo group

Placebo with Dietary Sources of Vitamins

Placebo Comparator group

Description:

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.

Treatment:

Combination Product: Dietary Sources

Other: Placebo

Antioxidants(Vitamins A,C,E) plus GSH, plus Centrum

Active Comparator group

Description:

Persons assigned to the study medication, and are continuing the take an oral RDA supplementation, in the form of Centrum.

Treatment:

Dietary Supplement: Centrum

Other: Antioxidants (Vitamins A,C,E) plus GSH

Antioxidants (Vitamins A,C, E) plus GSH

Active Comparator group

Description:

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.

Treatment:

Other: Antioxidants (Vitamins A,C,E) plus GSH

Placebo plus Centrum

Active Comparator group

Description:

Persons assigned to placebo, who have been on oral RDA supplementation, who would continue to do so throughout the study.

Treatment:

Dietary Supplement: Centrum

Other: Placebo