Keratoconus
Conditions
Brief 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
Detailed description
Among omega-3 polyunsaturated fatty acids (PUFAs), docosahexaenoic acid (DHA, C22:6-n3), a critical component of cell membrane phospholipids, exerts pleiotropic effects at both central and peripheral levels with health benefits in many aspects of neuronal, immune, cognitive, and cardiovascular functions Clinical studies of dietary sup-plementation with a highly-concentrated DHA triglyceride have shown consistent an-ti-inflammatory, antioxidant, antiangiogenic, and antiproliferative effects targeting pathophysiological pathways involved in different eye diseases, including diabetic retinopathy and macular edema, ocular surface disorders, meibomian gland dysfuncton, and pseudoexfoliative glaucoma. Based on this experience, it was considered of interest to explore the antioxidant and anti-inflammatory potential of a highly-concentrated DHA triglyceride supplement in patients with keratoconus. For this purpose, a prospective preliminary study was designed to assess the effects of 3-month DHA nutritional supplementation on clinical variables, and inflammatory and oxidative stress biomarkers of patients with early and moderate keratoconus.
Interventions
DIETARY_SUPPLEMENTHighly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%)
Daily administration of 2 capsules of the study product (1000 mg DHA triglyceride) for 3 months
Sponsors
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of keratoconus stages I to III according to the Amsler-Krumeich classification * Non-contact lens wearers * No history of previous corneal surgery * Capacity to volunteer and willing and able to follow the study protocol
Exclusion criteria
* Advanced keratoconus (stage IV of the Amsler-Krumeich classification * Other ectasias (e.g. iatrogenic 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 anti-inflammatory drugs * Use of nutritional supplements including omega-3 fatty acids, vitamins and minerals (unless a washout period of 1 month had been established) * Hypersensitivity to fish proteins * Pregnant women * Refusal to sign the written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal topography | Baseline and after 3 months of supplementation (end of study) | Changes of ophthalmological parameters |
| Anti-inflammatory variables | Baseline and after 3 months of supplementation (end of study) | cytokine levels IL-1beta, IL-4, IL-6, IL-10, IL-18, TNFalpha, VEGF-A |
| Antioxidant variables | Baseline and after 3 months of supplementation (end of study) | Changes in plasma total antioxidant capacity (TAC), malondialdehyde (MDA) and glutathione (GSH), and GSH/GSSH ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipidomic variables | Baseline and after 3 months of supplementation (end of study) | Serum levels of DHA, arachidonic acid (ARA), n-6 PUFA/n-3 PUFA, omega-3 index |
Countries
Spain
Outcome results
None listed