Effect of Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation on Macular Sensitivity in Patients With High Myopia
High Myopia
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 2
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 70 Real
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
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\*\*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).
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento simple
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change in contrast sensitivity function (LogCS) at 6 months
Plazo: 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).
Medidas secundarias
Change in systemic skin carotenoid levels
Plazo: 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.
Otras medidas
Change in macular integrity index
Plazo: 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.
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Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Asociación para Evitar la Ceguera en México, I.A.P . (APEC)Mexico City, Mexico City, MexicoEstado desconocido
Equipo y fechas
- Patrocinador principal
- Asociación para Evitar la Ceguera en México
- Inicio del estudio
- 14 dic 2023 Real
- Finalización primaria
- 18 may 2026 Real
- Finalización del estudio
- 18 may 2026 Real
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Effect of Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation on Macular Sensitivity in Patients With High Myopia
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026