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Completed

NCT Number: NCT05446948

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

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.

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Key information

Conditions

Proliferative Diabetic Retinopathy Vitrectomy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Medical University Eye Hospital

Tianjin, 300386, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with vitreous hemorrhage and tractional retinal detachment (TRD) confirmed by fundus image and B ultrasound examination, consistent with the diagnosis of severe proliferated diabetic retinopathy (PDR).
  • Patient that could follow up postoperatively at the clinic for 6 months more.
  • All the surgeries were performed by one well-experienced retinal surgeon.

Exclusion criteria

  • Corneal lesions affecting operative field, such as corneal opacity or scar; History of vitreoretinal surgery;
  • External eye infections;
  • History of systemic thromboembolism;
  • Uncontrolled hypertension or hyperglycemia;
  • Coagulation abnormalities or currently using anticoagulant drugs other than aspirin;
  • Unable to meet postoperative position requirements;
  • Unable to be followed up regularly.

Treatment and study plan

beveled 27G+ vitrectomy system

Device

The device is a novel 27G+ vitrectomy system, whose probe tip is beveled.

standard 25G+ vitrectomy system

Device

The device is a traditional instrument, and its probe tip is flat.

Primary outcomes

  1. the convenience in operating

    Time frame: during surgery

    The convenience will be indicated by times of ancillary instrument using, which evaluated based on the recorded surgical video.

  2. the efficiency of stripping membrane

    Time frame: during surgery

    It will be measured by the area of membrane removed per minute by probe.

Secondary outcomes

  1. best corrected visual acuity (BCVA)

    Time frame: baseline to 6 months post-surgery

    BCVA using a logMAR visual acuity chart method

Other outcomes

  1. intra-surgery complications

    Time frame: during surgery

    The complications include hemorrhage, iatrogenic retinal breaks, iatrogenic cataracts and occurrence of hypotony during the surgery. They can be detected by a microscope during surgery.

  2. Post-operative complications

    Time frame: within 6 months after surgery

    The complications include recurrent vitreous hemorrhage, retinal detachment, re-operation and ocular hypertension. They can be detected through ophthalmoscope, fundus image, B ultrasound, ophthalmotonometer and so on.

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Eye Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2022
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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