The Role of Antioxidant Supplementation in Keratoconus Patients

Phase 2

Withdrawn

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

• Registration Number: NCT02827747
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-11
• Status Verified: 2021-08
• Study Start: 2021-08-01
• Last Update Submitted: 2021-08-11
• Last Update Posted: 2021-08-16
• Primary Completion: 2022-07
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Read More

Exclusion Criteria

• would exclude smokers and former-smokers.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo with Dietary Sources of Vitamins	Placebo	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.
Antioxidants(Vitamins A,C,E) plus GSH, plus Centrum	Centrum	Persons assigned to the study medication, and are continuing the take an oral RDA supplementation, in the form of Centrum.
Placebo plus Centrum	Centrum	Persons assigned to placebo, who have been on oral RDA supplementation, who would continue to do so throughout the study.
Antioxidants (Vitamins A,C, E) plus GSH	Antioxidants (Vitamins A,C,E) plus GSH	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.
Placebo plus Centrum	Placebo	Persons assigned to placebo, who have been on oral RDA supplementation, who would continue to do so throughout the study.
Placebo with Dietary Sources of Vitamins	Dietary Sources	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.
Antioxidants(Vitamins A,C,E) plus GSH, plus Centrum	Antioxidants (Vitamins A,C,E) plus GSH	Persons assigned to the study medication, and are continuing the take an oral RDA supplementation, in the form of Centrum.

Primary Outcome Measures

Name	Time	Method
Change in Visual Acuity Measured by Snellen Chart	Baseline to 24 months

Secondary Outcome Measures

Name	Time	Method
Plasma level of Glutathione (GSH)	Baseline to 24 months	Blood draws to look at plasma level of GSH
Change in cornea thickness as measured by video keratography	Baseline to 24 months
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
Plasma level of Vitamin E	Baseline to 24 months	Blood draws to look at plasma level of Vitamin E

Trial Locations

Locations (1)

Bascom Palmer Eye Institute-- Palm Beach Gardens; 🇺🇸 Palm Beach Gardens, Florida, United States