A Randomized Controlled Trial of Branched-Chain Amino Acid Supplementation for Preventing Myopia Progression
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 104
- 试验地点
- 1
研究概览
简要总结
This study is a randomized controlled trial designed to evaluate whether branched-chain amino acid (BCAA) supplementation can help slow the progression of myopia in young adults.
Eligible participants will be randomly assigned to receive either BCAA supplementation combined with standard spectacle correction or standard spectacle correction with a matching placebo. The intervention period will last approximately six months.
Participants will undergo regular follow-up examinations, including measurements of visual acuity, refractive error, axial length, intraocular pressure, and other ocular parameters. Additional assessments such as ocular imaging (including OCTA), physical examinations, and blood tests will also be performed to evaluate eye health and metabolic indicators.
The main purpose of this study is to investigate whether BCAA supplementation can provide a safe and effective nutritional strategy to slow myopia progression and improve understanding of the relationship between amino acid metabolism and ocular growth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Ophthalmic examiners and personnel performing blood sample collection are also blinded to group assignment, although they are not involved in outcome evaluation.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy university students aged 18-25 years;
- •Spherical equivalent refraction (for eyes without prior corneal refractive surgery): SE ≤ -0.50 D;
- •Corrected visual acuity ≥ 0.8;
- •Corneal curvature 40 D-46 D;
- •Good compliance and ability to cooperate with follow-up and examinations;
- •Willingness and ability to participate in this study and sign the informed consent form.
排除标准
- •Strabismus, amblyopia, or other pathological ocular changes;
- •Systemic diseases affecting refractive development and allergic constitution, such as diabetes, metabolic syndrome, etc.;
- •Active eye disease or history of ophthalmic surgery;
- •Use of orthokeratology lenses or other myopia-control interventions within the past 6 months;
- •Use of BCAA-related supplements within the past 6 months, or serum BCAA levels outside the reference range;
- •Considered by the responsible physician to be unable to participate or unable to comply with the study requirements;
- •Abnormal liver or kidney function.
研究组 & 干预措施
BCAA Supplementation Group
Participants receive daily oral branched-chain amino acid (BCAA) supplementation in addition to standard spectacle correction. The intervention is administered for approximately 6 months to evaluate its effect on myopia progression and ocular parameters.
干预措施: Branched-Chain Amino Acids (BCAA) Supplementation (Dietary Supplement)
Control Group
Participants in the control group will receive standard spectacle correction combined with a placebo identical in appearance to the BCAA supplement, without active BCAA ingredients. They will be followed for approximately 6 months to evaluate myopia progression and ocular outcomes.
研究者
Weina Liu
Associate Professor
Southeast University, China