Status:
COMPLETED
Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS)
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Cataract
Eligibility:
All Genders
55-75 years
Phase:
PHASE3
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-mine...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
1020 Patients enrolled
Trial Details
Trial ID
NCT00309387
Start Date
May 1 1995
End Date
May 1 2007
Last Update
May 6 2013
Active Locations (1)
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1
Dpt. Scienze Otorino-Odonto Oftalmologiche, University of Parma
Parma, Italy, 43100