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Updated: Dec 28, 2025

Monitoring Dynamic Growth of Retinal Vessels in Oxygen-Induced Retinopathy Mouse Model
Published on: April 2, 2021
Lutein supplementation and retinopathy of prematurity: a meta-analysis
Francesco Cota1, Simonetta Costa1, Carmen Giannantonio1
1Department of Woman and Child Health, Obstetrics and Neonatology Area, Division of Neonatology, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
Insights
Oral lutein and zeaxanthin did not prevent retinopathy of prematurity in preterm infants. Further trials are needed to confirm if these carotenoids reduce transfusion needs in neonates.
Area of Science:
- Ophthalmology
- Neonatology
- Nutritional Science
Background:
- Retinopathy of prematurity (ROP) is a serious retinal disorder in preterm infants.
- Carotenoids, like lutein and zeaxanthin, are antioxidants with potential protective roles.
- Their role in preventing ROP requires rigorous investigation.
Purpose of the Study:
- To evaluate the efficacy and safety of oral lutein for preventing ROP in preterm neonates.
- To determine if lutein supplementation impacts ROP incidence.
- To assess the impact on other neonatal morbidities.
Main Methods:
- Systematic search for randomized or quasi-randomized controlled trials.
- Inclusion criteria: preterm neonates (≤32 weeks gestation), oral L/Z vs. placebo.
- Analysis of data from three RCTs involving 406 participants.
Main Results:
- Oral lutein and zeaxanthin did not significantly reduce the incidence of ROP.
- No reduction in the risk of bronchopulmonary dysplasia, sepsis, necrotizing enterocolitis, or mortality was observed.
- A potential reduction in transfusion requirements warrants further investigation.
Conclusions:
- Current evidence does not support the use of oral lutein for ROP prevention in preterm infants.
- The potential benefit regarding blood transfusions requires dedicated, separate trials.
- Further research is needed to clarify the role of carotenoids in neonatal eye health.
Background:
Retinopathy of prematurity (ROP) is a multifactorial retinal disorder characterized by an abnormal vascular development of the retina of the preterm infants. Carotenoids are natural pigments that are synthesized by all plants and some microorganisms where they play a role in photoprotection and coloration. Lutein and zeaxanthin (L/Z) are two carotenoids identified as the major components of the macular pigment. Recently it has been suggested that lutein and its isomer zeaxanthin may act as antioxidant agents and that they may prevent ROP.
Objective:
The primary objective of this study is to assess the safety and effectiveness of oral lutein in the prevention of retinopathy of prematurity in preterm neonates.
Study Design:
We conducted a systematic search for randomized or quasi-randomized controlled trials without any language or publication year restriction. The studies have to recruit preterm neonates ≤32 completed weeks of gestation and to compare the administration of oral L/Z at any dosage or duration, versus placebo in order to prevent ROP.
Result:
Data from three RCT with a total of 406 participants failed to show any reduction in ROP incidence nor the risk of BPD, sepsis, NEC and mortality. It may reduce the number of transfusions but this result has to be assessed in a separate ad hoc trial.

