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Completed
NCT05756062
Supplementation With a Highly-Concentrated Docosahexaenoic Acid (DHA) Triglyceride in Patients With Keratoconus
Conditions: Keratoconus
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 34
Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Location: Spain
Summary
The goal of this randomized controlled preliminary study is to assess 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 of patients with keratoconus.The main questions it aims to answer are:Improvements in ophthalmological parameters.Increase in antioxidant capacity, decrease in inflammatory status, and changes in lipidomic biomarkers.Participants are patients with keratoconus who will be given the nutraceutical supplementation for 3 months.If there is a comparison group: Researchers will compare patients with keratoconus not given the nutraceutical formulation to see differences in the study variables
Eligibility Criteria
Inclusion Criteria:Diagnosis of keratoconus stages I to III according to the Amsler-Krumeich classificationNon-contact lens wearersNo history of previous corneal surgeryCapacity to volunteer and willing and able to follow the study protocolExclusion Criteria:Advanced keratoconus (stage IV of the Amsler-Krumeich classificationOther ectasias (e.g.
iatrogenic secondary to ocular surface surgery with excimer laser, radial keratotomy, traumatic corneal ectasia, etc.)Eyelid alterationsPrevious ocular surgeryAny ocular or systemic condition that may affect the interpretation of resultsGlaucoma or ocular hypertensionHistory of ocular trauma, infection or inflammationCurrent treatment with topical or anti-inflammatory drugsUse of nutritional supplements including omega-3 fatty acids, vitamins and minerals (unless a washout period of 1 month had been established)Hypersensitivity to fish proteinsPregnant womenRefusal to sign the written informed consent
Source: ClinicalTrials.gov (NCT05756062). StuddyBuddy aggregates publicly available trial information.