A Phase 2 interventional study of Lutein + meso-zeaxanthin + zeaxanthin (LMZ) in High Myopia, sponsored by Asociación para Evitar la Ceguera en México. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Asociación para Evitar la Ceguera en México · Phase 2, Interventional, and Treatment
This clinical study evaluates whether six months of oral supplementation with lutein, zeaxanthin, and meso-zeaxanthin affects retinal sensitivity in adults with high myopia. Macular sensitivity is assessed using microperimetry, and outcomes are compared with those of a control group of patients with high myopia who do not receive supplementation.
This prospective, longitudinal, controlled, randomized, interventional clinical trial was conducted in adults with high myopia without other significant ophthalmic abnormalities.
Participants were allocated in a 1:1 ratio to an experimental group receiving one oral capsule of a triple-carotenoid formulation daily for six months or to a control group receiving no supplementation.
Each capsule contained 10 mg of lutein, 10 mg of meso-zeaxanthin, and 2 mg of zeaxanthin.
Assessments included best-corrected visual acuity, contrast sensitivity, macular microperimetry, and skin carotenoid levels at baseline, three months, and six months. The National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) was administered at baseline and at six months.
The main variable of interest was mean macular sensitivity measured using the MAIA microperimeter. Participants were followed for six months, and adverse events associated with supplementation were recorded.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's enrollment of 70 is below the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Asociación para Evitar la Ceguera en México is the lead sponsor of 60 studies on the registry; 6 are open to participants now.
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**Inclusion Criteria:**
**Exclusion Criteria:**
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received one oral softgel capsule daily with meals for six months. Each capsule contained 10 mg of lutein, 10 mg of meso-zeaxanthin, and 2 mg of zeaxanthin.
Dietary Supplement: Lutein + meso-zeaxanthin + zeaxanthin (LMZ)
Participants assigned to the control group received no carotenoid supplementation and continued their usual diet throughout the six-month observation period.
One oral softgel capsule containing 10 mg of lutein, 10 mg of meso-zeaxanthin, and 2 mg of zeaxanthin was administered daily with meals for six months.
Change in contrast sensitivity function (LogCS) at 6 months
Contrast sensitivity was assessed using the Rabin Contrast Sensitivity Test with an adaptive algorithm at a spatial frequency of 6 cycles per degree (CPD). Results were expressed in logarithmic contrast sensitivity units (LogCS).
Time frame: Baseline and 6 months (with an additional assessment at 3 months).
Change in systemic skin carotenoid levels
Skin carotenoid levels were measured using the Lifemeter system based on pressure-mediated reflectance spectroscopy. Three measurements were obtained per participant, and the average measurement value was used for analysis.
Time frame: Baseline, 3 months, and 6 months.
Change in macular integrity index
The macular integrity index was calculated by comparing each participant's retinal sensitivity map with an age-adjusted normative database.
Time frame: Baseline, 3 months, and 6 months.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Asociación para Evitar la Ceguera en México