Supplementation With a Highly-Concentrated Docosahexaenoic Acid (DHA) Triglyceride in Patients With Keratoconus

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Status

Completed

Conditions

Keratoconus

Treatments

Dietary Supplement: Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%)

Study type

Interventional

Funder types

Other

Identifiers

NCT05756062

PI_77

Details and patient eligibility

About

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

Full 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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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