The effect of lutein supplementation on macular pigment density in patients who have undergone cataract surgery

Prospective, open, pilot study of oral supplementation with lutein in patients having undergone cataract surgery: effect on macular pigment density

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71306406

Enrollment

Registered

2009-11-25

Start date

2006-07-05

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Eye Diseases Other cataract

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026