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

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.

Study Overview

• Status: Completed
• Conditions: Proliferative Diabetic Retinopathy; Vitrectomy
• Intervention / Treatment: Device: beveled 27G+ vitrectomy system; Device: standard 25G+ vitrectomy system

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin, China, 300386
    • Tianjin Medical University Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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).
2. Patient that could follow up postoperatively at the clinic for 6 months more.
3. All the surgeries were performed by one well-experienced retinal surgeon.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: beveled 27G+ group; The group of patients underwent vitrectomy with a beveled 27G+ vitrectomy system.	Device: beveled 27G+ vitrectomy system; The device is a novel 27G+ vitrectomy system, whose probe tip is beveled.
Active Comparator: 25G+ group; The group of patients underwent vitrectomy with a standard 25G+ vitrectomy system.	Device: standard 25G+ vitrectomy system; The device is a traditional instrument, and its probe tip is flat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
best corrected visual acuity (BCVA)	BCVA using a logMAR visual acuity chart method	baseline to 6 months post-surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
intra-surgery complications	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.	during surgery
Post-operative complications	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.	within 6 months after surgery

Collaborators and Investigators

• Sponsor: Tianjin Medical University Eye Hospital
• Investigators: Principal Investigator: Dr. Li, Tianjin Medical University Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: 2021KY-27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No