Phase 3
N=1,020
Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS)
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT00309387 ↗Enrolled (actual)
1,020
Serious AEs
74.5%
Results posted
Apr 2012
Primary outcome: Primary: Number of Participants Showing Development or Progression of Age-related Cataract or Undergoing Cataract Surgery During Follow-up — 227; 255 participants — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Centrum (Dietary_supplement); Placebo (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- National Eye Institute (NEI)
- Primary completion
- May 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Showing Development or Progression of Age-related Cataract or Undergoing Cataract Surgery During Follow-up |
227; 255 | 0.03 sig |
| SECONDARY Number of Participants Showing Development or Progression of Nuclear Lens Opacities |
84; 118 | — |
| SECONDARY Number of Participants Showing Development or Progression of Cortical Lens Opacities |
96; 118 | — |
| SECONDARY Number of Participants Showing Development or Progression of Posterior Subcapsular Opacities |
74; 37 | — |
| SECONDARY Number of Participants Undergoing Cataract Surgery |
88; 90 | — |
| SECONDARY Number of Participants With a Decrease in Visual Acuity |
144; 139 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00309387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.