Role of Xanthophylls in Visual Function (NCT05794074) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Role of Xanthophylls in Visual Function
48 participantsStarted 2023-04-01
Plain-language summary
Ecy of lutein supplementation alone, or zeaxanthin supplementation alone, or a combination of both, compared to placebo, on the evolution of macular pigment density (MPOD) measured by fundus photography in XANTH-deficient patients receiving enteral nutrition.
Who can participate
Age range16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* On exclusive enteral nutrition for at least 6 months
* Exclusive enteral nutrition that is intended to be continued for at least 6 more months.
* No XANTH supplementation in the last 6 months.
* Able to sit up to allow visual examinations to be performed
* Sufficient understanding to perform visual examinations, at the discretion of the physician
* Written consent signed by the patient or agreement of their carer, trusted person, relative, family for patients with cognitive impairment (assessed using an MMS test). A patient with an MMSE test result ≤ 24 will be considered as having cognitive disorders.
Exclusion Criteria:
* Current treatment with hydroxychloroquine or any other drug known to cause ocular toxicity
* Visually impaired patient: patient unable to read text (font size 11) at close range, with visual correction if the patient usually wears it
* Unoperated cataracts in both eyes
* Pregnant or breastfeeding woman
* Patient under legal protection: guardianship or curatorship
* Participation in other research in the same field of dietary supplementation, which may interfere with the results of this research.
Secondary exclusion criteria :
* Absence of XANTH (lutein and zeaxanthin) deficiency\* in the blood sample taken at inclusion.
* Physical, ophthalmological or cognitive characteristics, evaluated at the Quinze-Vingt ophthalmological examination, which do not allow a reliable measurement of MPOD or of all the settings of visual function.