VitrectomyNCT05710458
Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter
A study testing 25 gauge 20,000 cpm Hypervit Dual Blade and 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter in people with Vitrectomy and Epiretinal Membrane, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This prospective randomised controlled trial will be conducted to investigate that increasing the vitrectomy cutting rate from 10,000 cut/min to 20,000 cut/min will result more efficiency and shorter core vitrectomy time, and it is equally safe as compared to the current 10,000 cut/min. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitrectomy, Epiretinal Membrane, Macular Hole
- What is being tested?
- 25 gauge 20,000 cpm Hypervit Dual Blade and 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2021to 30 Nov 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years of age who are undergoing vitrectomy for the following conditions:
- Macular hole
- Epimacular membrane
- Vitreous hemorrhage
- Primary retinal detachment
Who cannot join
- Patient who is
- unable to give proper consent
- previous vitrectomy or scleral buckle surgery
- cases requiring silicone oil tamponed
- undergoing repeated retinal detachment surgery
- undergoing surgery for tractional diabetic retinopathy
Trial locations and contacts
1 site in 1 country.
About this study
This prospective randomised controlled trial will be conducted to investigate that increasing the vitrectomy cutting rate from 10,000 cut/min to 20,000 cut/min will result more efficiency and shorter core vitrectomy time, and it is equally safe as compared to the current 10,000 cut/min. We plan to target the patients undergoing for vitrectomy for common vitreoretinal pathology. Our plan is to conduct a randomised study with 2 arms, one with the higher cutting rate (20,000 cut/min) versus a second arm using the existing system 10,000 cuts/min.
Read the detailed description
In addition, we will measure the core vitrectomy duration by Constellation Vision System stopwatch. We will count the duration when the vitrectomy probe enter into the eye to the moment the performing the air/fluid exchange by shaving the peripheral vitreous to complete the vitrectomy. For our second outcome measure to prove the no-inferiority of intraoperative and postoperative complications patients will have 3 months follow up visits.
- Being tested
- 25 gauge 20,000 cpm Hypervit Dual Blade, 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter
- Medical subject headings
- Epiretinal Membrane, Retinal Perforations, Vitreous Hemorrhage, Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25 gauge 20,000 cpm Hypervit Dual BladeDevice
Also called 20K
Vitrectomy blade with increased cutting rate to 20,000 cut/min
25 gauge 10,000 cpm Ultravit Vitrectomy CutterDevice
Also called 10K
Existing Vitrectomy blade with cutting rate 10,000 cut/min
| Study group | Role | What they receive |
|---|---|---|
| 25 gauge 20,000 cpm Hypervit Dual Blade | Experimental | New vitrectomy blade with higher cutting rate Receives: Device: 25 gauge 20,000 cpm Hypervit Dual Blade |
| 25 gauge 10,000 Ultravit vitrectomy cutter | Active comparator | Existing vitrectomy blade with cutting rate 10,000 cut/min Receives: Device: 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Core vitrectomy
Measurement of core vitrectomy duration by Constellation Vision System
Measured: intraoperative (From the moment probe enter into the eye till performing the air/fluid exchange to complete the vitrectomy)
Secondary outcomes (1)
Non-inferiority of intraoperative and postoperative complication
Safety and Efficacy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Jul 2021
- Primary completion12 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VitrectomyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nicholas Fung, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710458
- Sponsor's protocol ID
- 20K
- Status last verified
- Jan 2023
- First submitted
- 25 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: By direct contact to the corresponding author or PI
Publications
O'Malley C, Heintz RM Sr. Vitrectomy with an alternative instrument system. Ann Ophthalmol. 1975 Apr;7(4):585-8, 591-4.
PubMed 1147502Rizzo S, Genovesi-Ebert F, Belting C. Comparative study between a standard 25-gauge vitrectomy system and a new ultrahigh-speed 25-gauge system with duty cycle control in the treatment of various vitreoretinal diseases. Retina. 2011 Nov;31(10):2007-13. doi: 10.1097/IAE.0b013e318213623a.
PubMed 21685823
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter
- ClinicalTrials.gov ID
- NCT05710458
- Acronym / sponsor ID
- 20K
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 2 Feb 2023 (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.
This prospective randomised controlled trial will be conducted to investigate that increasing the vitrectomy cutting rate from 10,000 cut/min to 20,000 cut/min will result more efficiency and shorter core vitrectomy time, and it is equally safe as compared to the current 10,000 cut/min. We plan to target the patients undergoing for vitrectomy for common vitreoretinal pathology. Our plan is to conduct a randomised study with 2 arms, one with the higher cutting rate (20,000 cut/min) versus a second arm using the existing system 10,000 cuts/min.
Detailed description
In addition, we will measure the core vitrectomy duration by Constellation Vision System stopwatch. We will count the duration when the vitrectomy probe enter into the eye to the moment the performing the air/fluid exchange by shaving the peripheral vitreous to complete the vitrectomy. For our second outcome measure to prove the no-inferiority of intraoperative and postoperative complications patients will have 3 months follow up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25 gauge 20,000 cpm Hypervit Dual Blade | Experimental | Device: 25 gauge 20,000 cpm Hypervit Dual BladeNew vitrectomy blade with higher cutting rate |
| 25 gauge 10,000 Ultravit vitrectomy cutter | Active comparator | Device: 25 gauge 10,000 cpm Ultravit Vitrectomy CutterExisting vitrectomy blade with cutting rate 10,000 cut/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient over 18 years of age who are undergoing vitrectomy for the following conditions:
Key exclusion criteria (6 listed)
- Patient who is
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 |
|---|---|---|
| 25 gauge 20,000 cpm Hypervit Dual BladeAlso: 20KVitrectomy blade with increased cutting rate to 20,000 cut/min | Device | 25 gauge 20,000 cpm Hypervit Dual Blade |
| 25 gauge 10,000 cpm Ultravit Vitrectomy CutterAlso: 10KExisting Vitrectomy blade with cutting rate 10,000 cut/min | Device | 25 gauge 10,000 Ultravit vitrectomy cutter |
Primary outcome
Duration of Core vitrectomy
Time frame: intraoperative (From the moment probe enter into the eye till performing the air/fluid exchange to complete the vitrectomy)
Measurement of core vitrectomy duration by Constellation Vision System
1 secondary outcome
Non-inferiority of intraoperative and postoperative complication
Time frame: 3 months
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 2 Feb 2023.
- Background: PubMed 1147502O'Malley C, Heintz RM Sr. Vitrectomy with an alternative instrument system. Ann Ophthalmol. 1975 Apr;7(4):585-8, 591-4.
- Background: PubMed 21685823Rizzo S, Genovesi-Ebert F, Belting C. Comparative study between a standard 25-gauge vitrectomy system and a new ultrahigh-speed 25-gauge system with duty cycle control in the treatment of various vitreoretinal diseases. Retina. 2011 Nov;31(10):2007-13. doi: 10.1097/IAE.0b013e318213623a.
- Individual participant dataSharing planned: Yes. By direct contact to the corresponding author or PI
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25 gauge 20,000 cpm Hypervit Dual Blade and 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter in people with Vitrectomy and Epiretinal Membrane, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 6 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 2 Feb 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 Hong Kong. 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?
Duration of Core vitrectomy (time frame: intraoperative (From the moment probe enter into the eye till performing the air/fluid exchange to complete the vitrectomy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05710458, which also lists 2 linked publications.
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 2 Feb 2023.