Multicenter study of Orthokeratorogy for infancy using " Breath-O Correct"

Not Applicable

• Conditions: myopia and myopic astigmatism

• Registration Number: JPRN-UMIN000012922
• Lead Sponsor: Keio University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Those who is correspond to any one of the following conditions, and who is considered to be inappropriate by the doctors, must be excluded from the research. 1) Patient with acute or sub-acute inflammation of anterior eye part. 2) Patient with eye infection. 3) Patient with uveitis. 4) Patient with cornea perception. 5) Patient with corneal epithelium defect. 6) Patient with eyelid abnormality. 7) Patient with lacrimal apparatus disease. 8) Patient who may suffer allergen reaction or exacerbation on eye surface or eye adnexa (that cannot controlled by ocular instillation), due to the use of contact lenses or contact lens solutions. 9) Patient who had keratorefractive surgery. 10) Patient with indication of keratoconus or other corneal disease. 11) Pregnant (potentially pregnant) or breastfeeding women. 12) Patient with immune disorders such as AIDS, autoimmune disorder, or diabetic. 13) Patient with any other eye disease that may effect to the cornea, conjunctiva, or eyelid, or with injury or malformation. 14) Patient with eye hyperemia or foreign body sensation. 15) Patient with systemic disease, or patient with potential systemic disease which may be effected by wearing Breath-O-Correct. 16) Patient who might not be able to comply with instructions by the doctors. 17) Patient who might not be able to properly use or take care Breath-O-Correct. 18) Patient who might not be able to attend for periodical examination. 19) Patient who might not be able to properly adopt hygiene management of Breath-O-Correct. 20) Patient who is extremely nervous. 21) Patient who usually stay in a dry environment (ex. Continuous air-conditioner use). 22) Patient with jobs that require continuous stable vision, and who need to stop working due to an un-regularly change of eye sight. 23) Any other reasons based on the doctors' judgment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified