Clinical trial NCT05446948: Observation of the Efficacy of Different Vitrectomy Systems to Treat Proliferative Diabetic Retinopathy
Official title: Comparison of the Efficacy of Standard 25 Gauge (25G)+ and Beveled 27 Gauge (27G)+ Vitrectomy Systems in Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proliferative Diabetic Retinopathy
Vitrectomy
Lead sponsor: Tianjin Medical University Eye Hospital
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the convenience in operating
timeFrame: during surgery
measure: the efficiency of stripping membrane
timeFrame: during surgery
Secondary outcomes:
measure: best corrected visual acuity (BCVA)
timeFrame: baseline to 6 months post-surgery
Other outcomes:
measure: intra-surgery complications
timeFrame: during surgery
measure: Post-operative complications
timeFrame: within 6 months after surgery
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
Study officials:
affiliation: Tianjin Medical University Eye Hospital
name: Dr. Li
role: PRINCIPAL_INVESTIGATOR
References: