Status:
WITHDRAWN
Augmented Macular Pigment-containing Nutraceutical and Central Visual Function
Lead Sponsor:
University of the Incarnate Word
Collaborating Sponsors:
Guardion Health Sciences, Inc.
Conditions:
Glaucoma
Glaucoma Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 p...
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 carote...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04676126
Start Date
May 1 2021
End Date
May 1 2022
Last Update
October 4 2022
Active Locations (1)
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1
Ophtalmology Clinic of William E Sponsel
San Antonio, Texas, United States, 78215