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Research on the safety and performance of new synchronous optical glass tube devices - a multi-cente

2026-09-04 12:46:31 ‍⚕️ Sources:PubMed 医学文献
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Research on the safety and performance of new synchronous optical glass tube devices - a multi-cente

In order to confirm the clinical safety and overall performance of MINIVISC® PLUS (an ophthalmic device with clinical safety and overall performance), we conducted a multi-center study at 6 locations in Sweden and Belgium. For subjects who need to undergo anterior corneal surgery, we included the scope of the study. The study consists of two parts.

The first part is a trial phase, where subjects need to undergo anterior corneal surgery. The second part is an observation phase, where subjects undergo anterior corneal surgery according to their needs. In phase A (90-day follow-up), a randomized comparison trial (randomized comparison trial) was conducted.

In phase B (thirty days after surgery), the eyes were treated with Minivisc® Plus, followed by follow-up for 30 days. The main endpoint indicator is 30 mm column level of IOP during the 7 day follow-up. The main endpoint indicator is 30 mm column level of IOP during the 7 day follow-up.

The main endpoint indicator is 30 mm column level of IOP during the 7 day follow-up. The main endpoint indicator is 30 mm column level of IOP during the 7 day follow-up. In phase A (90-day follow-up), a randomized comparison trial was conducted.

In phase B (30 days after surgery), the eyes were treated with Minivisc® Plus for 30 days. The main endpoints were the 30 mm column level of IOP (IPS) during the 7 days following surgery. In phase A (90-day follow-up), a randomized comparison trial was conducted.

In phase B (30 days after surgery), the eyes were followed up with Minivisc® Plus for 30 days. The main endpoint indicator was the 30 mm column level of the IOP during the 7-day follow-up period. The main endpoints were the level of 30 millimetres of IOP during the 7-day follow-up period.

The secondary endpoints included post-operative inflammation, room water penetration cell density (ECD), surgeon-reported equipment performance and adverse events (AEs) and equipment defects (DDs). In total, 163 eyes participated in the study: in the first phase (A), only 25 eyes received Minivisc® Plus and 29 eyes received Healon GV® Pro; All the surgical eyes were included in the study: in the second phase C, 25 eyes received Minivisc® Plus and 29 eyes received Healon GV® Pro; treatment; in the second phase D, 109 eyes received Minivisc® Pro; Plus and 109 eyes received Healon GV® Pro. All the surgical eyes were included in the study: 25 eyes received Minivisc® Plus and 29 eyes received Healon GV® Pro.

In the third phase F. 109 eyes received Minivisc® Plus and 109 eyes received Healon GV® Pro. It should be pointed out that the above content is based on international public research findings and is for reference in HealthCop and does not constitute clinical advice.

If you have any health questions, please consult professional medical personnel.

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