Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS)

Phase 3

Completed

Brief Summary: The Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS) is a 13-year study designed primarily to evaluate the safety and efficacy of a vitamin-mineral supplement (Centrum) containing recommended daily-allowance dosage (RDA) in preventing age-related cataract or delaying its progression in participants with early or no cataract at baseline.

Detailed Description: Despite dramatic increase in the rates of cataract surgery during the last decades, age-related cataract is still responsible for about 50% of cases of severe visual impairment in developing countries, and for high and growing health care costs in western countries. CTNS was designed to complement the U.S. Age-Related Eye Disease Study (AREDS) by evaluating a much broader spectrum of nutrients at RDA dosages. Whereas about 60% of the AREDS control group was taking RDA dose multivitamin supplements, none of the participants in CTNS had taken any type of nutritional supplement for at least one year before the qualification visit. Therefore, the CTNS will be able to evaluate the effect of RDA doses versus no supplementation at all. CTNS and AREDS will use similar procedures, including those for grading the presence and severity of lens changes.

CTNS is a randomized,parallel group, placebo controlled, double blinded, single center, intervention trial.

Primary Outcomes: photographic evaluation of a prespecified increase from baseline in nuclear, cortical, or posterior subcapsular cataract (PSC) opacity grades or cataract surgery.

Secondary Outcomes: increase in type-specific opacity grade, cataract surgery, and visual acuity loss from baseline \> or = 15 letters.

Patients will be followed for a maximum of 10 years.

Recruitment & Eligibility

Inclusion Criteria

Clinical and photographic diagnosis of early or no age-related cataract
Participants with early cataract must have at least one eligible eye with VA score 20/32 or better
Participants with no cataract must have VA score 20/32 or better in both eyes.

Exclusion Criteria

Advanced cataract
Bilateral aphakia or pseudophakia
Any ocular disease or condition that might complicate the future evaluation of cataract
Regular use of nutritional supplements
Failure to take at least 75% of run-in medication
Cancer with evidence of recurrence in the past 5 years
Major cerebral or cardiovascular events in past 12 months
Current participation to other clinical trials
Any condition likely to prevent adherence to CTNS follow-up schedule

Arm && Interventions

Group	Intervention	Description
Centrum	Centrum	multivitamin-mineral supplement. RDA dosage. 1 tablet a day for the whole study duration.
placebo	Placebo	placebo pills. One tablet a day for the whole study duration.

Primary Outcome Measures

Name	Time	Method
Number of Participants Showing Development or Progression of Age-related Cataract or Undergoing Cataract Surgery During Follow-up	at yearly intervals from baseline for approximately ten years	number of participants in whom any of the following occur in at least one eligible eye during follow-up: cataract surgery; nuclear opacity: a 1.5 U increase in opalescence from baseline; cortical opacity: a 10% increase in area within a standard 5 mm circle area of the lens from baseline; posterior subcapsular opacity: a 5% increase in area within a standard 5 mm circle area of the lens from baseline.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Showing Development or Progression of Nuclear Lens Opacities	at yearly intervals from baseline for approximately ten years	number of participants with a 1.5 U increase in nuclear opalescence from baseline in at least one eligible eye during follow-up
Number of Participants Showing Development or Progression of Cortical Lens Opacities	at yearly intervals from baseline for approximately ten years	Number of participants with a 10% increase in area of cortical opacity within a standard central 5 mm circle of the lens from baseline in at least one eligible eye during follow-up
Number of Participants Showing Development or Progression of Posterior Subcapsular Opacities	at yearly intervals from baseline for approximately ten years	Number of participants with a 5% increase in area of posterior subcapsular opacity within a standard central 5 mm circle of the lens from baseline in at least one eligible eye during follow-up
Number of Participants Undergoing Cataract Surgery	at 6 month intervals from baseline for approximately 10 yrs	number of participants undergoing cataract surgery in at least one eligible eye during follow-up
Number of Participants With a Decrease in Visual Acuity	at 6 month intervals from baseline for approximately 10 yrs	Number of participants with a decrease in best corrected visual acuity score from baseline of \> 15 letters in at least one eligible eye during follow-up