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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: National Eye Institute (NEI)

Current Primary Outcome: 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 ]

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.


Original Primary Outcome: Photographic evaluation of incidence and progression of "any" lens event and of specific cataract types.

Current Secondary Outcome:

  • Number of Participants Showing Development or Progression of Nuclear Lens Opacities [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


Original Secondary Outcome: Incidence and progression rates and risk factors for the disease.

Information By: National Eye Institute (NEI)

Dates:
Date Received: March 29, 2006
Date Started: May 1995
Date Completion:
Last Updated: April 30, 2013
Last Verified: April 2013