European Nutrition in Glaucoma Management Trial

NCT04460365 | Completed

• 1 other identifier: 1/378/1535
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

European Nutrition in Glaucoma Management (ENIGMA) trial will evaluate the effect of 18-month supplementation with lutein, zeaxanthin and meso-zeaxanthin on macular pigment (MP) levels, vision, cognition and serum biomarkers of inflammation and oxidative stress in glaucoma patients. This study comprises a randomised, placebo controlled and double masked clinical trial designed to establish MP response to supplementation with lutein, zeaxanthin and meso-zeaxanthin over an 18-month period. The study will also investigate the relationship between macular pigment, cognitive function, oxidative stress and inflammation, and determine the impact of dietary supplementation on vision, retinal structure, quality of life and cognitive function among glaucoma subjects.

Conditions

Glaucoma, Open-Angle

Keywords

multisensory integration; macular pigment; lutein; zeaxanthin; meso-zeaxanthin; cognitive function; glaucoma

Outcome Measures

Primary Outcomes (1)

• Change in MPOD in response to treatment from baseline at 18 months

  Change in MPOD measured at each study visit from baseline to 18 months will be evaluated between active and placebo arms

  18 months

Secondary Outcomes (11)

• Change in multisensory integration from baseline following 18 months supplementation

  18 months

• Change in flanker task scores (reaction time and attention) from baseline following 18 months supplementation

  18 months

• Change in SKT (Syndrom-Kurztest) score from baseline following 18 months supplementation

  18 months

• Change in verbal fluency (FAS score) from baseline following 18 months supplementation

  18 months

• Change in verbal fluency (animal fluency test) from baseline following 18 months supplementation

  18 months

Study Arms (2)

Active

ACTIVE COMPARATOR

Softgel capsules: 10 mg Lutein, 2 mg zeaxanthin, 10 mg meso-zeaxanthin once a day with a meal for 18 months

Dietary Supplement: 10 mg Lutein, 2 mg zeaxanthin, 10 mg meso-zeaxanthin

Placebo

PLACEBO COMPARATOR

Identical capsule containing no active ingredients

Other: Placebo

Interventions

10 mg Lutein, 2 mg zeaxanthin, 10 mg meso-zeaxanthin DIETARY_SUPPLEMENT

This is a lutein (10mg), zeaxanthin (2mg) and meso-zeaxanthin (10mg) one-a-day food supplement which combines all three macular carotenoids. These three nutrients are found at the back of the eye, at the macula, where they form the macular pigment (yellow colour). Meso-zeaxanthin is particularly concentrated at the centre of this pigment. Lutein and zeaxanthin can be found in fruits and dark green leafy vegetables and meso-zeaxanthin is present in some species of fish and seafood.

Active

Placebo OTHER

Softgel capsule containing sunflower oil (no active ingredients)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Open-angle glaucoma patients aged 18 years or older
• Primary open-angle glaucoma (POAG)
• Normal-tension glaucoma (NTG)
• Pseudoexfoliative glaucoma
• Pigment dispersion glaucoma
• Best corrected visual acuity of better than 6/12 in the study eye (logMAR \<0.3)
• Either gender
• Able to give informed consent, make the required study follow-up visits and adhere to trial protocol

You may not qualify if:

• Underlying ocular disease such as age-related macular degeneration, diabetic retinopathy or moderate to significant cataract (patients with established cataract who are likely to progress)
• Best corrected visual acuity of worse than 6/12 in the study eye (logMAR \> 0.3)
• History of diabetes mellitus, any type of dementia (e.g. Alzheimer's has been shown to be associated with lower macular pigment levels) or other significant systemic condition that might affect capacity to complete the trial
• MMSE score \< 26
• Individuals taking dietary macular pigment supplements (containing lutein, zeaxanthin and meso-zeaxanthin, such as MacuShield, Ocuvite Lutein/Complete, I-Caps etc.) in the past 6 months

Sponsors & Collaborators

• Centre for Eye Research Ireland: lead

Study Sites (1)

Centre for Eye Research Ireland

Dublin, Co. Dublin, D07 H6K8, Ireland

Location

Related Publications (1)

• Loughman J, Loskutova E, Butler JS, Siah WF, O'Brien C. Macular Pigment Response to Lutein, Zeaxanthin, and Meso-zeaxanthin Supplementation in Open-Angle Glaucoma: A Randomized Controlled Trial. Ophthalmol Sci. 2021 Jul 11;1(3):100039. doi: 10.1016/j.xops.2021.100039. eCollection 2021 Sep.

  PMID: 36247822 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

Lutein; Zeaxanthins; meso-zeaxanthin

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• James Loughman, PhD

  Head of the Centre for Eye Research Ireland, Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: July 7, 2020
• Study Start: October 1, 2017
• Primary Completion: September 17, 2020
• Study Completion: September 17, 2020
• Last Updated: August 6, 2021

Record last verified: 2021-08

Locations

IE (1)