The effect of lutein supplementation on macular pigment density in patients who have undergone cataract surgery
| ISRCTN | ISRCTN71306406 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71306406 |
| Secondary identifying numbers | #462 |
- Submission date
- 04/11/2009
- Registration date
- 25/11/2009
- Last edited
- 25/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Catherine Creuzot-Garcher
Scientific
Scientific
Hopital Général Service d'ophtalmologie
3 rue de Faubourg Raines
Dijon Cedex
BP151921034
France
Study information
| Study design | Prospective open monocentric non-controlled pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prospective, open, pilot study of oral supplementation with lutein in patients having undergone cataract surgery: effect on macular pigment density |
| Study acronym | Lutein Pilot Study |
| Study objectives | 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(s) | Local medical ethics committee (Comite consultatif de protection des personnes dans la recherche biomedicale de Bourgogne) approved on the 9th May 2006 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Lutein |
| Primary outcome measure | 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 study start date | 05/07/2006 |
| Completion date | 24/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | At least 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/07/2006 |
| Date of final enrolment | 24/10/2008 |
Locations
Countries of recruitment
- France
Study participating centre
Hopital Général Service d'ophtalmologie
Dijon Cedex
BP151921034
France
BP151921034
France
Sponsor information
Dr. Mann Pharma GmbH, Bausch & Lomb Group (Germany)
Industry
Industry
Brunsbütteler Damm 165 - 173
Berlin
13581
Germany
| Website | http://www.bausch-lomb.de/ |
|---|---|
"ROR" |
https://ror.org/049ncrn81 |
Funders
Funder type
Industry
Dr. Mann Pharma GmbH, Bausch & Lomb Group (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
