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

Sponsor
Tianjin Medical University Eye Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05446948
Collaborator
(none)
50
1
2
17.9
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: beveled 27G+ vitrectomy system
  • Device: standard 25G+ vitrectomy system
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of the Efficacy of Standard 25 Gauge (25G)+ and Beveled 27 Gauge (27G)+ Vitrectomy Systems in Proliferative Diabetic Retinopathy
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. the convenience in operating [during surgery]

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

  2. the efficiency of stripping membrane [during surgery]

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

Secondary Outcome Measures

  1. best corrected visual acuity (BCVA) [baseline to 6 months post-surgery]

    BCVA using a logMAR visual acuity chart method

Other Outcome Measures

  1. intra-surgery complications [during surgery]

    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.

  2. Post-operative complications [within 6 months after surgery]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tianjin Medical University Eye Hospital Tianjin China 300386

Sponsors and Collaborators

  • Tianjin Medical University Eye Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhenchuan Zheng, Principal investigator, Tianjin Medical University Eye Hospital
ClinicalTrials.gov Identifier:
NCT05446948
Other Study ID Numbers:
  • 2021KY-27
First Posted:
Jul 7, 2022
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2022