Endovascular cannulation with a microneedle for RVO or RAO

JRCT ID: jRCTs051190021

Registered date:21/05/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Retinal vein occlusion and retinal artery occlusion
• Date of first enrollment: 15/05/2017
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Vitreous surgery including the peripheral shaving is performed by 25-gauge system. Thereafter, connect the microneedle to the VFC (viscous fluid exchange component) of the vitreous surgical device (Constellation, Alcon) and adjust the injection volume of the liquid medicine with the foot switch. As a result, problems such as injection resistance due to manual operation are resolved. Also, in order to prevent deterioration of visibility due to bleeding immediately after puncture, we will have a backflash needle on the left hand and prepare to bleed immediately from the punctured blood vessel. Drug solution to be placed in the VFC dissolves 400,000 units of t-PA vial to 4 ml with physiological saline, and 0.05 ml (5000 units) of it is injected into the retinal vessel. Implantation is scheduled to be performed for 1 to 3 minutes in pulses, rather than constant pressure, expecting thrombus movement.

Outcome(s)

Primary Outcome

1 Background information, past medical history, complications
2 Evaluation of retinal vascular blood flow by fluorescein angiography
3 preoperative visual acuity and postoperative visual acuity
4 Evaluation of preoperative and postoperative morphological change of the macula with an optical coherence tomograph
5 Evaluation of period from onset and therapeutic effect

• Secondary Outcome: Comparison of visual acuity between pre-surgery and 1 month and 3 month after surgery, and comparison of pre-surgery and 1 month and 3 month post-operative foveal thickness in the same patient correspond to Mann-Whitney U test or t test.

Key inclusion & exclusion criteria

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

Include criteria

1 Over 20 years old at the time of this research registration
2 The patients stay in hospital for one week after vitrectomy
3 The patients agree with the document to be explained in obtaining informed consent
4 There is no history of cerebrovascular disorders such as cerebral infarction and drugs used in this study don't induce a deteriorating factor.

• Exclude criteria: At the time of registration, the cases in which drugs in this study are expected to influence past diseases.

Related Information

• Primary Sponsor: Kojima Kentaro
• Secondary ID(s): UMIN000024593