Skip to main content
OpenTrials
Completed

NCT Number: NCT00309387

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dpt. Scienze Otorino-Odonto Oftalmologiche, University of Parma

Parma, 43100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Centrum

Dietary Supplement

Multivitamin/mineral supplement containing US RDA levels of nutrients. 1 tablet a day for the expected duration of follow-up (on average 10 yrs).

Placebo

Other

placebo tablets manufactured to mimic Centrum tablets.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

National Eye Institute (NEI)

Nih

Registry information

Acronym: CTNS

Important dates

Study start
1995
Primary completion
2007
Study completion
2007
First posted
Mar 31, 2006
Registry last updated
May 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.