VitrectomyHYPENCT04404296
Pars Plana Vitrectomy With 25-gauge 20000 Cpm, Bevel-tip Cutter
A study testing 25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomy in people with Vitrectomy and Retinal Detachment, run by Peregrine Eye and Laser Institute at 1 site in Philippines.
Trial summary
Report efficiency and clinical outcomes using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe among eyes with various vitreo-retinal diseases Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitrectomy, Retinal Detachment, Vitreous Hemorrhage
- What is being tested?
- 25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Apr 2021to 30 Jan 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
- All eyes undergoing pars plana vitrectomy with surgically amenable vitreoretinal disease.
Who cannot join
- History of prior PPV, glaucoma, scleral thinning, and active or recent history of (<3 months) ocular or extra-ocular infection
Trial locations and contacts
1 site in 1 country.
Philippines1 site, 1 recruiting
- Recruiting
Peregrine Eye and Laser Instittute
Makati City, MM, 1209
Rheamel Navarro, +63288900115, rheanavarro82@gmail.com
Pik Sha Chan, MD
About this study
Official title: Efficiency and Clinical Outcomes of 25-gauge, Bevel-tip, 20000 Cuts-per-minute, Pars Plana Vitrectomy
Report efficiency and clinical outcomes using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe among eyes with various vitreo-retinal diseases
Read the detailed description
We will evaluate the efficiency and clinical outcomes of pars plana vitrectomy using a 25-gauge, bevel-tip, 10 and 20000 cpm vitrectomy probe among eyes with 8 main surgical indications. Main outcome measures included efficiency measures, postoperative pain and complications.
- Conditions
- Vitrectomy, Retinal Detachment, Vitreous Hemorrhage, Macular Holes, Epiretinal Membrane, Dislocated Intraocular Lens Into Vitreous
- Being tested
- 25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomy
- Keywords
- Small gauge vitrectomy probe, 20000 cut per minute, Microincisional vitrectomy system
- Medical subject headings
- Retinal Detachment, Vitreous Hemorrhage, Retinal Perforations, Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomyDevice
Pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe
| Study group | Role | What they receive |
|---|---|---|
| 25-gauge 20000 PPV | Other | Eyes will undergo pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe Receives: Device: 25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time: Total
From insertion of first trocar to removal of last trocar, measured in seconds using stopwatch
Measured: 6 months
Secondary outcomes (3)
Pain scoring
Visual Analogue scale (0 to 4)
Measured: 6 months
Adverse events
Intra- and Postoperative complications
Measured: Up to 3 months after surgery
Number of times ancillary instruments placed in eye
Count
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Apr 2021
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitrectomyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional case series
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peregrine Eye and Laser Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Harvey Siy Uy, Peregrine Eye and Laser Institute
- Investigators
- Harvey S Uy, MD, Principal investigator, Peregrine Eye and Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404296
- Sponsor's protocol ID
- 20190101
- Acronym
- HYPE
- Status last verified
- Jun 2021
- First submitted
- 20 Apr 2020
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Clinical Outcomes of 25-gauge, Bevel-tip, 20000 Cuts-per-minute, Pars Plana Vitrectomy
- ClinicalTrials.gov ID
- NCT04404296
- Acronym / sponsor ID
- HYPE / 20190101
- Conditions
- Vitrectomy, Retinal Detachment, Vitreous Hemorrhage, Macular Holes, Epiretinal Membrane, Dislocated Intraocular Lens Into Vitreous
- Keywords
- Small gauge vitrectomy probe, 20000 cut per minute, Microincisional vitrectomy system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peregrine Eye and Laser InstituteUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 27 May 2020 (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.
Report efficiency and clinical outcomes using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe among eyes with various vitreo-retinal diseases
Detailed description
We will evaluate the efficiency and clinical outcomes of pars plana vitrectomy using a 25-gauge, bevel-tip, 10 and 20000 cpm vitrectomy probe among eyes with 8 main surgical indications. Main outcome measures included efficiency measures, postoperative pain and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional case series
| Arm | Type | Receives |
|---|---|---|
| 25-gauge 20000 PPV | Other | Device: 25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomyEyes will undergo pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All eyes undergoing pars plana vitrectomy with surgically amenable vitreoretinal disease.
Key exclusion criteria (1 listed)
- History of prior PPV, glaucoma, scleral thinning, and active or recent history of (<3 months) ocular or extra-ocular infection
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, bevel-tip, 20000 cut per minute pars plana vitrectomyPars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe | Device | 25-gauge 20000 PPV |
Primary outcome
Operative time: Total
Time frame: 6 months
From insertion of first trocar to removal of last trocar, measured in seconds using stopwatch
3 secondary outcomes
Pain scoring
Time frame: 6 months
Adverse events
Time frame: Up to 3 months after surgery
Number of times ancillary instruments placed in eye
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- 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.
Harvey S Uy, MD principal investigator
Peregrine Eye and Laser Institute
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, bevel-tip, 20000 cut per minute pars plana vitrectomy in people with Vitrectomy and Retinal Detachment, run by Peregrine Eye and Laser Institute at 1 site in Philippines.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Jun 2021. 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 Philippines. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harvey S Uy, MD (639175239332, harveyuy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time: Total (time frame: 6 months). 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 4 Jun 2021.