Status:
COMPLETED
European Nutrition in Glaucoma Management Trial
Lead Sponsor:
Centre for Eye Research Ireland
Conditions:
Glaucoma, Open-Angle
Eligibility:
All Genders
18+ years
Phase:
NA
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, cognit...
Detailed Description
This is a research study looking at the effects of dietary MP supplementation in glaucoma patients. Glaucoma can cause irreversible visual impairment. Current treatment modalities only halt disease pr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04460365
Start Date
October 1 2017
End Date
September 17 2020
Last Update
August 6 2021
Active Locations (1)
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1
Centre for Eye Research Ireland
Dublin, Co. Dublin, Ireland, D07 H6K8