Proliferative Diabetic RetinopathyNCT05446948
Observation of the Efficacy of Different Vitrectomy Systems to Treat Proliferative Diabetic Retinopathy
A study testing beveled 27G+ vitrectomy system and standard 25G+ vitrectomy system in people with Proliferative Diabetic Retinopathy and Vitrectomy, run by Tianjin Medical University Eye Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Proliferative Diabetic Retinopathy, Vitrectomy
- What is being tested?
- beveled 27G+ vitrectomy system and standard 25G+ vitrectomy system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
- Patient that could follow up postoperatively at the clinic for 6 months more.
- All the surgeries were performed by one well-experienced retinal surgeon.
Who cannot join
- Corneal lesions affecting operative field, such as corneal opacity or scar; History of vitreoretinal surgery;
- External eye infections;
- History of systemic thromboembolism;
- Uncontrolled hypertension or hyperglycemia;
- Coagulation abnormalities or currently using anticoagulant drugs other than aspirin;
- Unable to meet postoperative position requirements;
- Unable to be followed up regularly.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Proliferative Diabetic Retinopathy, Vitrectomy
- Being tested
- beveled 27G+ vitrectomy system, standard 25G+ vitrectomy system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beveled 27G+ vitrectomy systemDevice
The device is a novel 27G+ vitrectomy system, whose probe tip is beveled.
standard 25G+ vitrectomy systemDevice
The device is a traditional instrument, and its probe tip is flat.
| Study group | Role | What they receive |
|---|---|---|
| beveled 27G+ group | Experimental | The group of patients underwent vitrectomy with a beveled 27G+ vitrectomy system. Receives: Device: beveled 27G+ vitrectomy system |
| 25G+ group | Active comparator | The group of patients underwent vitrectomy with a standard 25G+ vitrectomy system. Receives: Device: standard 25G+ vitrectomy system |
What is being measured
The primary outcome is the main question the study is designed to answer.
the convenience in operating
The convenience will be indicated by times of ancillary instrument using, which evaluated based on the recorded surgical video.
Measured: during surgery
the efficiency of stripping membrane
It will be measured by the area of membrane removed per minute by probe.
Measured: during surgery
Secondary outcomes (1)
best corrected visual acuity (BCVA)
BCVA using a logMAR visual acuity chart method
Measured: baseline to 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start11 Jul 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenchuan Zheng, Tianjin Medical University Eye Hospital
- Investigators
- Dr. Li, Principal investigator, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446948
- Sponsor's protocol ID
- 2021KY-27
- Status last verified
- Jun 2023
- First submitted
- 29 Jun 2022
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Standard 25 Gauge (25G)+ and Beveled 27 Gauge (27G)+ Vitrectomy Systems in Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT05446948
- Acronym / sponsor ID
- 2021KY-27
- Conditions
- Proliferative Diabetic Retinopathy, Vitrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tianjin Medical University Eye HospitalUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| beveled 27G+ group | Experimental | Device: beveled 27G+ vitrectomy systemThe group of patients underwent vitrectomy with a beveled 27G+ vitrectomy system. |
| 25G+ group | Active comparator | Device: standard 25G+ vitrectomy systemThe group of patients underwent vitrectomy with a standard 25G+ vitrectomy system. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
- Patient that could follow up postoperatively at the clinic for 6 months more.
- All the surgeries were performed by one well-experienced retinal surgeon.
Key exclusion criteria (7 listed)
- Corneal lesions affecting operative field, such as corneal opacity or scar; History of vitreoretinal surgery;
- External eye infections;
- History of systemic thromboembolism;
- Uncontrolled hypertension or hyperglycemia;
- Coagulation abnormalities or currently using anticoagulant drugs other than aspirin;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beveled 27G+ vitrectomy systemThe device is a novel 27G+ vitrectomy system, whose probe tip is beveled. | Device | beveled 27G+ group |
| standard 25G+ vitrectomy systemThe device is a traditional instrument, and its probe tip is flat. | Device | 25G+ group |
Primary outcome
the convenience in operating
Time frame: during surgery
The convenience will be indicated by times of ancillary instrument using, which evaluated based on the recorded surgical video.
the efficiency of stripping membrane
Time frame: during surgery
It will be measured by the area of membrane removed per minute by probe.
1 secondary outcome
best corrected visual acuity (BCVA)
Time frame: baseline to 6 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Li principal investigator
Tianjin Medical University Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beveled 27G+ vitrectomy system and standard 25G+ vitrectomy system in people with Proliferative Diabetic Retinopathy and Vitrectomy, run by Tianjin Medical University Eye Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the convenience in operating (time frame: during surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.