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

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05446948
• Other study ID #: 2021KY-27
• Status: Completed
• Phase: N/A
• Start date: July 11, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Tianjin Medical University Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases
• Vitrectomy

Intervention

Device:
• beveled 27G+ vitrectomy system
The device is a novel 27G+ vitrectomy system, whose probe tip is beveled.
• standard 25G+ vitrectomy system
The device is a traditional instrument, and its probe tip is flat.

Locations

Country	Name	City	State
China	Tianjin Medical University Eye Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	the efficiency of stripping membrane	It will be measured by the area of membrane removed per minute by probe.	during surgery
Secondary	best corrected visual acuity (BCVA)	BCVA using a logMAR visual acuity chart method	baseline to 6 months post-surgery