myopia and myopic astigmatism
Conditions
Interventions
contact lens
Sponsors
Keio University School of Medicine
Department of Ophthalmology,Ehime University, School of Medicine Department of Ophthalmology,Kyoto Prefectural University of Medicine Universal View Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participant must meet all of the following conditions listed below; 1) Patient who is 6 years old to 16 years old (including 6 years old and 16 years old), at the time of the consent acquisition. 2) Patient with -1.00 to -4.00D myopia. 3) Patient with astigmatism (spherical power being less than 1/2 of cylindrical power, and less -0.75D). 4) Patient whom examiner is able to observe both eyes. 5) Patient who is able to attend the hospital during the research. 6) Patient whose parent is able to take care the RGP lenses. 7) Patient who is able to acquire a consent of his/her adult legal representative.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safty: uncorrected visual acuity Efficacy: Decrease of corneal endothelial cell density | — |
Countries
Japan
Contacts
Public ContactKazuno Negishi
Keio University School of Medicine Department of Ophthalmology
Outcome results
None listed