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

• Number of Participants Showing Development or Progression of Age-related Cataract or Undergoing Cataract Surgery During Follow-up [ Time Frame: at yearly intervals from baseline for approximately ten years ] [ Designated as safety issue: No ]
  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.
  
  

• Number of Participants Showing Development or Progression of Nuclear Lens Opacities [ Time Frame: at yearly intervals from baseline for approximately ten years ] [ Designated as safety issue: No ]
  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 [ Time Frame: at yearly intervals from baseline for approximately ten years ] [ Designated as safety issue: No ]
  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 [ Time Frame: at yearly intervals from baseline for approximately ten years ] [ Designated as safety issue: No ]
  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 [ Time Frame: at 6 month intervals from baseline for approximately 10 yrs ] [ Designated as safety issue: No ]
  number of participants undergoing cataract surgery in at least one eligible eye during follow-up
  
  
• Number of Participants With a Decrease in Visual Acuity [ Time Frame: at 6 month intervals from baseline for approximately 10 yrs ] [ Designated as safety issue: No ]
  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
  
  

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.