Time course changes of O-17 water in the eyes

JRCT ID: jRCTs031210082

Registered date:12/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Glaucoma
• Date of first enrollment: 24/06/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Intraocular administration of 0-17 labeled water

Outcome(s)

• Primary Outcome: Intraocular dynamics of O-17-labeled water
• Secondary Outcome: Safety by intraocular instillation of O-17-labeled water

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Both

Include criteria

1. Healthy subjects aged between 20 to 39 years old at informed consent
2. Subjects with corrected eyesight of 0.7 or more
3. Subjects who are judged by the investigator or research coordinator to be able to apply based on their own will and understand the contents of the explanatory document
4. Subjects who provide written informed consent

Exclude criteria

1. A history or complications of serious eye and brain diseases.
2. A history of eye surgery or those who have a history of eye trauma that is considered inappropriate for participation in this clinical study.
3. Serious or progressive complications, or those who have a history of these complications and are judged by the investigator to be ineligible for this study.
4. Controindication for MRI such as metabolic implant, tatoo in the upper body.
5. Claustrophobia or phobia of the dark.
6. Pregnant or may be pregnant.
7. A history of severe hypersensitivity to the drug.
8. Receiving the drug within 14 days before the MRI examination date.
9. Drug addiction or alcohol addiction.
10. Smoker.
11. Judged by the principal investigator or the investigator to be ineligible for this study.

Related Information

• Primary Sponsor: Obata Takayuki