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

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.

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,single group, single center, placebo controlled, double blinded, intervention trial.
Primary Outcomes: Photographic evaluation of incidence and progression of "any" lens event and of specific cataract types.
Secondary Outcomes: Incidence and progression rates and risk factors for the disease.
Patients will be followed for at least 9 years and last date for follow-up visits will be May 23, 2007.
Data Entry Closure Date: expected August 2007.
Study Completion Date: Expected March 22, 2008.

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.

• 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

Patient Recruitment Status:

No longer recruiting. Comments: The first patient was randomized on January 8, 1996. The last patient was randomized on April 10, 1998. A total of 1020 patients were randomized to the study.

Current Status of Study:

Ongoing. Comments: As of January 15, 2005, 100% of active participants have completed FV 2(12 months visit), 97% have completed FV 4 (24 months visit), 95 % have completed FV 6 (36 months visit), 92% have completed FV 8 (48 months visit), 88% have completed FV 10 (60 months visit), 79% have completed FV 12 (72 months visit), 72% have completed FV 14 (84 months visit), and 40% have completed FV 16 (96 months visit).

Results:

Not yet available.

Publications

Ferrigno L, Aldigeri R, Rosmini F, Sperduto RD, Maraini G, The Italian-American Cataract Study Group.: Associations between plasma levels of vitamins and cataract in the Italian-American Clinical Trial of Nutritional Supplements and Age-Related Cataract (CTNS): CTNS Report #2.  Ophthalmic Epidemiol  12: 71-80, 2005  

The CTNS Study Group: The Italian-American Clinical trial of Nutritional Supplements and Age-related Cataract (CTNS): design implications. CTNS report no 1.  Controlled Clin Trials  24: 815-829, 2003  




NEI Representative




William O'Donnell
National Eye Institute
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USA
Telephone: (301) 496-9059
Fax: (301) 496-7295


Resource Centers



Chairman's Office
Giovanni Maraini, M.D.
University of Parma
via Gramsci 14
Parma 43100
Italy
Telephone: +39-0521-980844 or +39-05
Fax: +39-0521-994820
Email: sally@unipr.it

Last Updated: 10/21/2005