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Endovascular cannulation with a microneedle for retinal vein occlusion or retinal artery occulusion (Endovascular cannulation with a microneedle for RVO or RAO)

Endovascular cannulation with a microneedle for RVO or RAO (Endovascular cannulation with a microneedle for RVO or RAO)

5

We examined 5 eyes of 5 patients, 3 males. The mean age of patients was 77.0 years, with an age range of 71 years to 90 years. The diagnosis of retinal vein occlusion was confirmed by fluorescence fundus angiography in 3 cases and retinal artery occlusion in 2 cases.

Date of consent acquisition from the first subject: May 15 2017. Date of follow-up completion for the last subject: December16 2019. The registration pace was 3 patients in 2017, and 4 patients in 2018. There were no registered patients since December, 2018.

Postoperative vitreous hemorrhage was observed in 2 of 5 patients, but it was absorbed spontaneously after surgery and did not affect visual acuity.

Primary outcome: Regarding the presence of complications, postoperative vitreous hemorrhage occurred in 2 of 5 patients, but gradually resolved spontaneously. Regarding the evaluation of retinal vascular blood flow by fluorescence fundus angiography, the primary endpoint, partial improvement was observed in two of five patients (60%) at one month after treatment, including a reduction in arm retinal circulation time. Primary outcome: visual acuities over time at 1month, 3months. The Best corrected visual acuity at the baseline was 1.48 logMAR units, and it gradually improved to 1.445, 1.39 logMAR units at 1 months and 3 months. Due to the limited number of patients, we did not perform a detailed analysis.

Five patients were enrolled in the study. In this study, endovascular treatment with tissue-type plasminogen activator for retinal vascular occlusion can be performed without major complications, but there are still issues such as the difficulty of the procedure. Because this study was conducted on an unexpectedly small number of patients, detailed statistical analysis could not be performed, and conclusions regarding efficacy and safety cannot be drawn.

Mar. 01, 2021

No

Due to the limited number of patients, we did not perform a detailed meta-analysis analysis.

https://jrct.mhlw.go.jp/latest-detail/jRCTs051190021

Kojima Kentaro

University Hospital Kyoto Prefectural University of Medicine

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, JAPAN

kenkojim@koto.kpu-m.ac.jp

Shinkai Yoichiro

University Hospital Kyoto Prefectural University of Medicine

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, JAPAN

+81-75-251-5578

yshinkai@koto.kpu-m.ac.jp

Complete

Dec. 27, 2016

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

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.

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

Both

Retinal vein occlusion and retinal artery occlusion

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.

D058449 and D015356

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

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.

+81-75-251-5337

Mar. 06, 2019

none