Augmented Macular Pigment-containing Nutraceutical and Central Visual Function

Study Overview
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Brief Summary
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The purpose of this study is to prospectively analyze changes in macular pigment optical density and dermal carotenoid levels as they relate to visual field function in patients prescribed a macular pigment-containing medical food (Lumega-Z), in combination with a topical carbonic anhydrase inhibitor.

Detailed Description
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This is a prospective double-masked, randomized controlled trial which evaluates central visual field function as it relates to macular pigment optical density, contrast sensitivity, and dermal carotenoid levels in the presence of a commercial macular pigment-containing medical food (Lumega-Z). Participants will be randomized to twelve weeks of supplement + dorzolamide or twelve weeks of placebo. All packaging of supplement and dorzolamide and the placebo will be identical and distributed by a third party. Both subjects and the investigators examining patients will be masked to placebo and experimental group assignment.

Official Title
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Augmented Macular Pigment Supplement and Pericentral Visual Function: a Randomized Controlled Trial

Conditions
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Glaucoma, Glaucoma Eye, Glaucoma, Open-Angle

Intervention / Treatment
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* Dietary Supplement: Lumega-Z
* Drug: Dorzolamide Hcl 2% Oph Soln
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Glaucoma diagnosis (H40. *) with abnormal visual field as measured by 30-2 Humphrey Perimetry (mean deviation < -2.00) Adequate IOP control (IOP > 7 mmHg and < 22 mmHg) by medical or surgical means measured by Goldman Applanation Tonometry for at least 3 months Visual field progression - decrease (more negative) in MD by 1.00 dB or more when compared to prior HVF) Refractive error ≤ 10 diopters and astigmatism ≤ 3 diopters Exclusion Criteria: BCVA worse than 20/200 Pt Is unable to tolerate MPOD, CS, dermal carotenoid measurement-taking procedures Loss of IOP control requires surgical intervention Patient already taking AREDS formula oral supplement Patient taking medication or dietary supplements that may interact with LM ingredients History of photosensitive epilepsy History of penetrating ocular trauma or vitrectomy History of ocular or orbital radiation therapy or is currently receiving chemotherapy Women who are nursing, pregnant, or are planning pregnancy Has a known adverse reaction (including sulfa allergy) and/or sensitivity to the study supplement or its ingredients including: N-acetyl-cysteine, acetyl-L-carnitine, L-taurine, quercetin, Co-enzyme Q-10, lutein, meso zeaxanthin, zeaxanthin, astazanthin, lycopene, alpha-lipoic acid. Currently enrolled in an investigational drug study or has used an investigational drug within 30 days prior to recruitment. Is planning on having ocular surgery at any time throughout the study duration, or had ocular surgery < 3 months before enrollment Native lens opacity ≥ grade 3 on ARLNS standard photograph Blue light filter intraocular lens

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective double-masked, randomized controlled study which compares pre- supplementation macular pigment optical density, contrast sensitivity, dermal carotenoid levels, and visual field status to post-supplement measurements of the same.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Subjects in the experimental arm will consume 1.5 Tbsp (22.2 mL) of a commercial macular pigment-containing medical food (liquid) once per day and use a carbonic anhydrase inhibitor topical eye drop (2% dorzolamide ophthalmic solution) three times per day in both eyes for 3 months. | Dietary Supplement: Lumega-Z<br>* Medical food which contains lutein, zeaxanthin, and meso-zeaxanthin<br>Drug: Dorzolamide Hcl 2% Oph Soln<br>* Topical carbonic anhydrase inhibitor<br>* Other names: Azopt;|
| Placebo Comparator: Placebo<br>Subjects in the placebo arm will consume 1.5 Tbsp (22.2 mL) of a placebo liquid which resembles the commercial macular pigment-containing medical food (liquid) in taste once per day and use a lubricating eye drop (0.5% sodium + 0.9% glycerin ophthalmic solution) three times per day in both eyes for 3 months. | Other: Placebo<br>* Specially formulated non macular pigment-containing formulation which tastes similar to the commercial medical food being evaluated in this study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pericentral Visual Function | Mean deviation and pattern standard deviation of 10-2 Humphrey visual field | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular Pigment Optical Density | Macular Pigment Optical Density measured by Mapcat SF | Monthly for 3 months | 
| Dermal Carotenoid Levels | Measured by Veggie Meter | Monthly for 3 months | 
| Contrast Sensitivity | Measured by Vector Vision CSV-2000 | Monthly for 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumega-Z, Macular Pigment, Macular Pigment Optical Density, Contrast Sensitivity, Humphrey Visual Field 10-2, Dermal Carotenoid, MapcatSF, Veggie Meter, Vector Vision, Pericentral Visual Field