Condition category
Eye Diseases
Date applied
04/11/2009
Date assigned
25/11/2009
Last edited
25/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Catherine Creuzot-Garcher

ORCID ID

Contact details

Hopital Général Service d'ophtalmologie
3 rue de Faubourg Raines
Dijon Cedex
BP151921034
France

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

http://www.bausch-lomb.de/

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

Publication citations

Additional files

Editorial Notes