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

Last updated: April 30, 2013
Sponsor: National Eye Institute (NEI)
Overall Status: Completed

Phase

3

Condition

Vision Loss

Eye Disorders/infections

Eye Disease

Treatment

N/A

Clinical Study ID

NCT00309387
NEI-110
  • Ages 55-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Advanced cataract

  • Bilateral aphakia or pseudophakia

  • Any ocular disease or condition that might complicate the future evaluation ofcataract

  • 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

Study Design

Total Participants: 1020
Study Start date:
May 01, 1995
Estimated Completion Date:
May 31, 2007

Study 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.

Connect with a study center

  • Dpt. Scienze Otorino-Odonto Oftalmologiche, University of Parma

    Parma, 43100
    Italy

    Site Not Available

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