the Effects of Fish Oil Supplements on Choroidal Thickness and Blood Flow Perfusion in Children and Adolescents (FOS)

Shanghai Eye Disease Prevention and Treatment Center

Status and phase: Completed; Phase 2

Conditions: Fish Oils

Treatments: Dietary Supplement: fish oil

Study type: Interventional

Funder types: Other

Identifiers

NCT06877494

YFZXYDK20240115

Details and patient eligibility

About

The goal of this clinical trial is to test the effect of fish oil supplement in terms of vision in children and adolescents. The main question it aims to answer is:

the differences in changes of choroidal thickness, choroidal blood flow, axial length, and visual acuity between the intervention group and the control group Participants will take the fish oil supplement. a baseline examination will be conducted, followed by follow-up visits at 15, 30, and 90 days after the start of the intervention.

Enrollment: 38 patients

Sex: All

Ages: 6 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age range: 6-9 years old, gender unspecified;
2. Equivalent spherical power after unilateral cycloplegic eye ranging from 0.75D to -0.5D, with astigmatism not exceeding 1.5D;
3. Best corrected visual acuity of at least 1.0;
4. Ability to sign an informed consent form with the presence and understanding of a parent or guardian.

Exclusion criteria

1. Allergy or intolerance to ω-3 PUFAs or cycloplegics;
2. Strabismus, history of eye surgery (including strabismus correction surgery), other eye diseases, or systemic diseases;
3. Currently using myopia prevention measures.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

no-treatment control group

No Intervention group

Description:

No intervention measures are applied

fish oil supplement group

Experimental group

Description:

Twice a day, with one dose of DHA 300mg: EPA 60mg, for a continuous intervention of 90 days

Treatment:

Dietary Supplement: fish oil