Macular Pigment and Glaucoma Trial

Macular Pigment and Glaucoma Trial: a placebo-controlled, double-masked study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN56985060

Enrollment

180

Registered

2013-10-02

Start date

2013-10-01

Completion date

Unknown

Last updated

2017-10-30

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

Conditions

Glaucoma and disability glare Eye Diseases Glaucoma, unspecified

Interventions

120 glaucoma participants Treatment arm - MacuShield® (N=60) Placebo arm (N=60) Duration of intervention: 6 months At baseline, all glaucoma participants will undergo detailed vision assessments s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Glaucoma patients or healthy controls aged 18 years and above 2. Either gender 3. Able to give informed consent, make the required study follow-up visits and adhere to study protocol

Exclusion criteria

Exclusion criteria: 1. Underlying ocular disease such as age-related macular degeneration, diabetic retinopathy or moderate to significant cataract (using Lens Opacity Classification System III grading) 2. Best corrected visual acuity of worse than 6/12 in the test eye 3. Previous ocular surgery other than for cataract extraction or glaucoma drainage procedure 4. Any individual who has a blue-light filter intraocular lens 5. Individuals who already are taking dietary MP supplementation

Design outcomes

Primary

Measure	Time frame
1. Macular pigment optical density (MPOD) response to dietary macular pigment (MP) supplementation in glaucoma patients. MPOD will be measured using the Macular Densitometer. 2. Visual response to dietary MP supplementation. Visual function assessments include the measurements of best corrected visual acuity (Logmar ETDRS chart), macular visual field test (Humphrey 10-2), glare and contrast sensitivities (Optec 6500 device) and photo-stress recovery time (MDD-2 Macular Adaptometer). Measured at baseline and repeated again at 6 months after intervention.	—

Measure

Time frame

1. Macular pigment optical density (MPOD) response to dietary macular pigment (MP) supplementation in glaucoma patients. MPOD will be measured using the Macular Densitometer. 2. Visual response to dietary MP supplementation. Visual function assessments include the measurements of best corrected visual acuity (Logmar ETDRS chart), macular visual field test (Humphrey 10-2), glare and contrast sensitivities (Optec 6500 device) and photo-stress recovery time (MDD-2 Macular Adaptometer). Measured at baseline and repeated again at 6 months after intervention.

—

Secondary

Measure	Time frame
1. Relationship between MP and visual function in glaucoma patients and healthy controls 2. Effect of MP supplementation on vision-related quality of life Scores from the GAL-9 and TyPE SPEC (vision-related quality of life) questionnaires will be compared before and after dietary MP supplementation.	—

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026