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

NCT05446948 | Completed DMC

• 1 other identifier: 2021KY-27
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• the convenience in operating

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

  during surgery

• the efficiency of stripping membrane

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

  during surgery

Secondary Outcomes (1)

• best corrected visual acuity (BCVA)

  baseline to 6 months post-surgery

Other Outcomes (2)

• intra-surgery complications

  during surgery

• Post-operative complications

  within 6 months after surgery

Study Arms (2)

beveled 27G+ group

EXPERIMENTAL

The group of patients underwent vitrectomy with a beveled 27G+ vitrectomy system.

Device: beveled 27G+ vitrectomy system

25G+ group

ACTIVE COMPARATOR

The group of patients underwent vitrectomy with a standard 25G+ vitrectomy system.

Device: standard 25G+ vitrectomy system

Interventions

beveled 27G+ vitrectomy system DEVICE

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

beveled 27G+ group

standard 25G+ vitrectomy system DEVICE

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

25G+ group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Eye Hospital: lead

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjin, 300386, China

Location

Study Officials

• Dr. Li

  Tianjin Medical University Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 7, 2022
• Study Start: July 11, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)