Augmented Macular Pigment-containing Nutraceutical and Central Visual Function

• Status: Not yet recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of the Incarnate Word
• Collaborator: Guardion Health Sciences, Inc.
• Treatments: Dorzolamide

Criteria

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