Effect of Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation on Macular Sensitivity in Patients With High Myopia
High Myopia
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 2
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 70 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
\*\*Inclusion Criteria:\*\*
- Adults aged 18 years or older.
- Both sexes.
- Clear ocular media (clear vitreous, cornea, and crystalline lens without abnormalities).
- High myopia, defined according to the International Myopia Institute (IMI) classification as a refractive error of ≥6.0 diopters and an axial length of ≥26.0 mm.
- Written informed consent.
\*\*Exclusion Criteria:\*\*
- Patients with structural changes associated with pathologic myopia, including posterior staphyloma, lacquer cracks, myopic choroidal neovascularization, and/or Fuchs spots.
- Patients with myopic maculopathy greater than category 1 (only category 0, corresponding to no myopic retinal degenerative lesions, and category 1, corresponding to tessellated fundus, were included).
- Patients with myopia-associated glaucomatous optic neuropathy.
- Patients with other retinal diseases or degenerations, including diabetic retinopathy and age-related macular degeneration.
- Patients using systemic medications that may cause macular toxicity.
- Patients with a history of oral antioxidant supplementation, regardless of whether the supplements contained macular carotenoids.
- Patients with known hypersensitivity to any component of the carotenoid formulation (LMZ).
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Single masked
Triple-carotenoid supplementation (LMZ)
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)
Control - observation only
Participants assigned to the control group received no carotenoid supplementation and continued their usual diet throughout the six-month observation period.
Lutein + meso-zeaxanthin + zeaxanthin (LMZ) DIETARY_SUPPLEMENT
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Change in contrast sensitivity function (LogCS) at 6 months
Time frame: Baseline and 6 months (with an additional assessment at 3 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).
Secondary measures
Change in systemic skin carotenoid levels
Time frame: Baseline, 3 months, and 6 months.
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.
Other measures
Change in macular integrity index
Time frame: Baseline, 3 months, and 6 months.
The macular integrity index was calculated by comparing each participant's retinal sensitivity map with an age-adjusted normative database.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
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1 locations
Asociación para Evitar la Ceguera en México, I.A.P . (APEC)Mexico City, Mexico City, MexicoStatus unknown
Study team and timeline
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Study start
- Dec 14, 2023 Actual
- Primary completion
- May 18, 2026 Actual
- Study completion
- May 18, 2026 Actual
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Effect of Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation on Macular Sensitivity in Patients With High Myopia
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026