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

NCT05446948 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-06-06

No results posted yet for this study

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.

Conditions

  • Proliferative Diabetic Retinopathy
  • Vitrectomy

Interventions

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.

Sponsors & Collaborators

  • Tianjin Medical University Eye Hospital

    lead OTHER

Principal Investigators

  • Dr. Li · Tianjin Medical University Eye Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2023-06-01
Completion
2023-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05446948 on ClinicalTrials.gov