Observation of the Efficacy of Different Vitrectomy Systems to Treat Proliferative Diabetic Retinopathy
NCT ID: NCT05446948
Last Updated: 2023-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2022-07-11
2023-06-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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beveled 27G+ group
The group of patients underwent vitrectomy with a beveled 27G+ vitrectomy system.
beveled 27G+ vitrectomy system
The device is a novel 27G+ vitrectomy system, whose probe tip is beveled.
25G+ group
The group of patients underwent vitrectomy with a standard 25G+ vitrectomy system.
standard 25G+ vitrectomy system
The device is a traditional instrument, and its probe tip is flat.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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Tianjin Medical University Eye Hospital
OTHER
Responsible Party
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Zhenchuan Zheng
Principal investigator
Principal Investigators
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Dr. Li
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University Eye Hospital
Locations
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Tianjin Medical University Eye Hospital
Tianjin, , China
Countries
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Other Identifiers
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2021KY-27
Identifier Type: -
Identifier Source: org_study_id
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