Glaucoma, Glaucoma Eye, Glaucoma, Open-Angle
Conditions
Keywords
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
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTLumega-Z
Medical food which contains lutein, zeaxanthin, and meso-zeaxanthin
DRUGDorzolamide Hcl 2% Oph Soln
Topical carbonic anhydrase inhibitor
OTHERPlacebo
Specially formulated non macular pigment-containing formulation which tastes similar to the commercial medical food being evaluated in this study
Sponsors
Guardion Health Sciences, Inc.
University of the Incarnate Word
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
A remotely located Guardion Health Sciences designee will utilize a computer-generated random number table to assign patients to placebo or experimental group. Subjects will have the supplement/placebo delivered to their homes in identical (except lot number) packaging.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pericentral Visual Function | 3 Months | Mean deviation and pattern standard deviation of 10-2 Humphrey visual field |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Macular Pigment Optical Density | Monthly for 3 months | Macular Pigment Optical Density measured by Mapcat SF |
| Dermal Carotenoid Levels | Monthly for 3 months | Measured by Veggie Meter |
| Contrast Sensitivity | Monthly for 3 months | Measured by Vector Vision CSV-2000 |
Countries
United States
Outcome results
None listed