Last updated: September 30, 2022
Sponsor: University of the Incarnate Word
Overall Status: Trial Not Available
Phase
4
Condition
Glaucoma
Treatment
N/AClinical Study ID
NCT04676126
20-11-005
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years
- Glaucoma diagnosis (H40. *) with abnormal visual field as measured by 30-2 HumphreyPerimetry (mean deviation < -2.00)
- Adequate IOP control (IOP > 7 mmHg and < 22 mmHg) by medical or surgical meansmeasured by Goldman Applanation Tonometry for at least 3 months
- Visual field progression - decrease (more negative) in MD by 1.00 dB or more whencompared to prior HVF)
- Refractive error ≤ 10 diopters and astigmatism ≤ 3 diopters
Exclusion
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 studysupplement 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 investigationaldrug within 30 days prior to recruitment.
- Is planning on having ocular surgery at any time throughout the study duration, or hadocular surgery < 3 months before enrollment
- Native lens opacity ≥ grade 3 on ARLNS standard photograph
- Blue light filter intraocular lens
Study Design
Study Start date:
May 01, 2021
Estimated Completion Date:
May 31, 2022
Study Description
Connect with a study center
Ophtalmology Clinic of William E Sponsel
San Antonio, Texas 78215
United StatesSite Not Available
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