Examination of suppressive effect by combined treatment of orthokeratology and atropine 0.01% ophthalmic solution on myopia progression

UMIN ID: UMIN000014362

Registered date:24/06/2014

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Myopia
• Date of first enrollment: 2014/06/30
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Orthokeratology contact lens
Atropine 0.01% ophthalmic solution

Outcome(s)

• Primary Outcome: Efficacy: Increase in axial length over a 2-year period
• Secondary Outcome: Safty: Decrease in corneal endothelial cell density over a 2-year period Efficacy: Increase in axial length over a 1-year period Safty: Decrease in corneal endothelial cell density over a 1-year period

Key inclusion & exclusion criteria

• Age minimum: 8years-old
• Age maximum: 12years-old
• Gender: Male and Female
• Exclude criteria: 1) Eye disorders such as strabismus and amblyopia 2) Systemic disorders such as cardiac or respiratory illness 3) Birth weight of less than 1500 g 4) History of hypersensitivity to atropine 5) Using of orthokeratology and/or atropine ophthalmic solutions

Related Information

• Primary Sponsor: Department of Ophthalmology, Saitama Medical Center, Jichi Medical University
• Secondary Sponsor: Konno Eye Clinic Omiya Hamada Eye Clinic
• Source(s) of Monetary Support: JSPS KAKENHI Grant Number JP26462646 from the Japan Society for the Promotion of Science,Universal View Co., Ltd.