Clinical trial NCT02827747: The Role of Antioxidant Supplementation in Keratoconus Patients
Official title: The Role of Antioxidants in Keratoconus Patients-A Randomized Controlled Trial of Oral Supplementation of Glutathione, Vitamin A, Vitamin C and Vitamin E
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Keratoconus
Keywords: Keratoconus progression
Vitamins and keratoconus
Vitamin supplementation
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Fight for Sight
First posted: 2016-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Visual Acuity Measured by Snellen Chart
timeFrame: Baseline to 24 months
Secondary outcomes:
measure: Change in cornea thickness as measured by video keratography
timeFrame: Baseline to 24 months
measure: Plasma level of Vitamin A
timeFrame: Baseline to 24 months
measure: Plasma level of Vitamin C
timeFrame: Baseline to 24 months
measure: Plasma level of Vitamin E
timeFrame: Baseline to 24 months
measure: Plasma level of Glutathione (GSH)
timeFrame: Baseline to 24 months
Other outcomes:
Locations:
city: Palm Beach Gardens
country: United States
facility: Bascom Palmer Eye Institute-- Palm Beach Gardens
state: Florida
Study officials:
affiliation: University of Miami
name: Ellen Koo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: