t-PA trial for central retinal artery occlusion

JRCT ID: jRCTs041190079

Registered date:19/11/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: central retinal artery occlusion
• Date of first enrollment: 28/03/2020
• Target sample size: 20
• Study type: Interventional
• Intervention(s): After hospitalization, Monteplase prepared as 80000unit/ml with saline is injected into the retinal vessel during vitrectomy

Outcome(s)

• Primary Outcome: Visual acuity at 12 weeks after the first operation
• Secondary Outcome: Changes in visual acuity and central retinal thickness at 12 weeks after the first operation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients older than 20
2.Diagnosed with central retinal artery occulusion within 24 hours
3.Treated with pars plana vitrectomy as an inpatient in this research facility
4.No history of cerebrovascular disease such as stroke,
and judged that drug used in this research is not deterioration factor
5.Obtain written informed consent

Exclude criteria

1.Expected that the drug influence previous disease
2.central retinal artery occlusion more than 24 hours after the onset
3.Pregnant, possibile pregnancy or hope for pregnancy during the study period

Related Information

• Primary Sponsor: Hayashi Atsushi