ATW-001

JRCT ID: jRCT2032210430

Registered date:19/11/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: myopia,myopia astigmatism
• Date of first enrollment: 11/01/2022
• Target sample size: 104
• Study type: Interventional
• Intervention(s): ATW-001 is customized according to the subject's eye condition and inserted through the corneal incision into the posterior chamber(back of the iris).

Outcome(s)

• Primary Outcome: far-sighted naked-eye visual acuity 1 year after surgery

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Both

Include criteria

Cases in which written consent was obtained from the patient himself / herself
Cases in which prescribed postoperative examinations may be possible during the study period
Cases where he/she can understand the contents of the consent explanation document and sign the consent form

Exclude criteria

Cases of active external ocular inflammation
Cases with cataract nuclear myopia
Not limited to nuclear cataracts, but also includes cases with abnormalities such as opacity or subluxation of the crystalline lens.
Cases with active endoocular inflammation associated with uveitis or scleritis
Cases with high intraocular pressure
Cases with systemic or immunodeficiency disorders that are likely to affect wound care, such as severe diabetes and severe atopic dermatitis
Cases which are pregnant or breastfeeding
Cases with superficial anterior chamber and corneal endothelial cell damage
Cases of glaucoma whose treatment cannot be controlled by drugs, etc.
Cases with systemic connective tissue disease
Cases with suspected or history of macular degeneration or macular edem
Cases with amblyopia or blindness in one eye
Cases with progressive lesions that affect vision excludes retinal lesions associated with myopia
Cases with ocular surface disease
Cases judged by the investigator to be inappropriate as subjects

Related Information

• Primary Sponsor: Ishibashi Taro