Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
#462
Study information
Scientific title
Prospective, open, pilot study of oral supplementation with lutein in patients having undergone cataract surgery: effect on macular pigment density
Acronym
Lutein Pilot Study
Study hypothesis
In this study will be tested the hypothesis that a 6 month treatment, after cataract surgery, of lutein at a dosage of 10 mg daily, significantly increases macular pigment optical density as measured by a Raman spectrometer. The null hypothesis, expected to be rejected, is that there is no difference between the measurement just after surgery and the measurement 6 months after surgery. An additional hypothesis, that a 2 month treatment of lutein increases macular pigment optical density before cataract surgery, will also be tested.
Ethics approval
Local medical ethics committee (Comite consultatif de protection des personnes dans la recherche biomedicale de Bourgogne) approved on the 9th May 2006
Study design
Prospective open monocentric non-controlled pilot study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cataract
Intervention
This was an open-label pilot study at a single site to assess if eight months of lutein supplementation results in a significant increase in macular pigment optical density and plasma lutein levels to protect the macula of subjects after cataract surgery.
There was no control group in this study.
A total of at least 40 subjects were planned for enrolment in this single site study. All included subjects received 10 mg soft capsules of lutein (containing lutein and vitamin E). Each subject was to swallow one capsule daily with a glass of water without chewing. The planned treatment duration was eight months.
Cataract surgery was to be scheduled two months after enrolment. One week after surgery, data was to be collected to establish baseline information for post-surgery MPOD.
A follow-up visit was planned for two months (+/- 7 days) following surgery and the final follow-up visit was planned for six months (+/- 2 weeks) after surgery.
Intervention type
Drug
Phase
Phase IV
Drug names
Lutein
Primary outcome measures
To check that lutein supplementation of 10 mg results in significant Macular pigment optical density (MPOD) increase to protect the macula of patients after cataract surgery and significant increase in lutein plasma levels
Secondary outcome measures
1. Macular pigment optical density increase after lutein supplementation before surgery to protect the macula during surgery
2. Plasma levels of lutein to check treatment compliance
3. Safety of oral lutein supplementation
Overall trial start date
05/07/2006
Overall trial end date
24/10/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Men or women aged over 55 years
2. Having to undergo cataract surgery on one eye (study eye) with extracapsular cataract extraction (ECCE) by phacoemulsification and insertion of a posterior chamber implant
3. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
At least 40
Participant exclusion criteria
1. Body mass index (BMI) greater than or equal to 29 kg/m^2
2. Poor pupillary dilation less than 6 mm with mydriatic drugs
3. Age-related maculopathy or macular degeneration (Age-Related Eye Disease Study [AREDS] class 2, 3 or 4)
4. Diabetic retinopathy
5. History of other progressive disease in the study eye which may complicate the assessment of pigment density
6. Known sensitivity to lutein, vitamin E or vehicules
7. Use of cholesterol-lowering drugs that act as bile acid binders (may interfere with carotenoid absorption) within the last month
8. Concomitant disease or therapy which could interfere with lutein absorption
9. Supplementation with carotenoids within the previous 6 months
10. Drastic change of food and/or food supplements within the last month
11. Involvement in the last 30 days in any investigational drug study
Recruitment start date
05/07/2006
Recruitment end date
24/10/2008
Locations
Countries of recruitment
France
Trial participating centre
Hopital Général Service d'ophtalmologie
Dijon Cedex
BP151921034
France
Sponsor information
Organisation
Dr. Mann Pharma GmbH, Bausch & Lomb Group (Germany)
Sponsor details
Brunsbütteler Damm 165 - 173
Berlin
13581
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Dr. Mann Pharma GmbH, Bausch & Lomb Group (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary