2.1. Design and Participants
ectasias, ectasia, inflammation, traumatic corneal ectasia, ocular trauma, infection, glaucoma, keratoconus, hypersensitivity
EYE DISEASES, ECTASIAS, ECTASIA, OCULAR HYPERTENSION, INFLAMMATION, INFECTION, SECONDARY, OXIDATIVE STRESS, GLAUCOMA, KERATOCONUS, ANTERIOR, HYPERSENSITIVITY
This was a single-center, prospective, randomized, and controlled preliminary study carried out between February 2019 and January 2022 at the Unit of Corneal and Anterior Eye Diseases of FISABIO Medical Ophthalmology Center (FOM) in Valencia, Spain. The primary objective of the study was to determine the effect of daily supplementation with a nutraceutical formulation of a highly concentrated DHA triglyceride plus minerals on ophthalmological parameters and biomarkers of oxidative stress and inflammation in blood samples. Secondary objectives were to assess changes in lipidomic biomarkers and correlations between ophthalmological variables and biomarkers of oxidative stress and inflammation in patients treated with the nutraceutical product.Eligible patients were men or women aged 18 years or older, diagnosed with keratoconus stages I to III according to the Amsler–Krumeich classification [Exclusion criteria were as follows: advanced keratoconus (stage IV of the Amsler–Krumeich classification); presence of other ectasias (including iatrogenic ectasia secondary to ocular surface surgery with excimer laser, radial keratotomy, traumatic corneal ectasia, etc.); eyelid alterations; previous ocular surgery; any ocular or systemic condition that may affect the interpretation of results; glaucoma or ocular hypertension; history of ocular trauma, infection, or inflammation; current treatment with topical or systemic anti-inflammatory drugs; use of nutritional supplements including omega-3 fatty acids, vitamins, and minerals (unless a washout period of 1 month has been established); hypersensitivity to fish proteins; pregnant women; refusal to sign the written informed consent; and patients deemed ineligible by the ophthalmologist.The study was conducted in accordance with the Declaration of Helsinki and approved by the Clinical Research Ethics Committee (CEIC) of FISABIO Medical Ophthalmology Center and the Foundation for the Promotion of Health and Biomedical Research in the Community of Valencia (protocol code PI_77, approval date 26 July 2018) (Valencia, Spain). All participants signed the written informed consent form.