NCT05446948

Observation of the Efficacy of Different Vitrectomy Systems to Treat Proliferative Diabetic Retinopathy

Comparison of the Efficacy of Standard 25 Gauge (25G)+ and Beveled 27 Gauge (27G)+ Vitrectomy Systems in Proliferative Diabetic Retinopathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Tianjin Medical University Eye Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

In recent years, vitrectomy has moved toward a minimally invasive vitrectomy surgery (MIV) system, which could effectively reduce the occurrence of operation complications, while reducing the time of post-operation recovery. With an improved design of bevel tip and a high cutting rate capacity of 10000cpm, Advanced ULTRAVIT® probes potentially provide an strong technical support for the application of MIV. The new probe facilitates great control during delicate surgical maneuvers, such as separating the hyaloid from the retinal surface, dissecting fibrovascular tissue off the surface of retina. However, there was no sufficient clinical evidence to support the benefits of Advanced ULTRAVIT ® probes in the complicated vitreoretinal surgery, such as proliferative diabetic retinopathy. More importantly, there is an urgent need of clinical evidence to support 10000cpm launch and conversion which is major objective of 2021 VR growth strategies.

Detailed description

This exploratory study, aiming to demonstrate the beneficial of 27 Gauge probe, which can be flexibly applied as a multifunctional tool for membrane removal by reducing frequencies of switching device, reducing the traction to eyeball during device entering and leaving the eye. Moreover, the outcomes from this study would be an strong evidence to support further comparative study to comprehensively demonstrate the superior function compare to current heavily used 5K 25 gauge probe.

Conditions

• Proliferative Diabetic Retinopathy
• Vitrectomy

Interventions

Type	Name	Description
DEVICE	beveled 27G+ vitrectomy system	The device is a novel 27G+ vitrectomy system, whose probe tip is beveled.
DEVICE	standard 25G+ vitrectomy system	The device is a traditional instrument, and its probe tip is flat.

Timeline

• Start date: 2022-07-11
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2022-07-07
• Last updated: 2023-06-06

Locations

1 site across 1 country: China