Vitreoretinal SurgeryNCT04412525
Comparative Study 27G Vitrectomy vs Larger Gauge Surgery
A study testing vitrectomy (27G gauge or larger needle) in people with Vitreoretinal Surgery, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Two-arm, mono-center, prospective, interventional comparative case study to compare postoperative recovery between the 27G and larger gauge surgical approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreoretinal Surgery
- What is being tested?
- vitrectomy (27G gauge or larger needle)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Jun 2020to 23 Jan 2021
- 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
- Patients aged over 18
- No prior vitrectomy surgery in the study eye (for the same eye)
- No prior inclusion in this trial
- Scheduled for vitrectomy for floater removal or macular surgery (including macular holes) without endotamponades such as PFCL, Gas, Silicone oil). (Air tamponade is allowed )
Who cannot join
- • Patients with serious heart, lung, liver, or kidney dysfunction
- Patients with proliferative diabetic retinopathy, endophthalmitis, uveitis, eyes with refraction >+5D or exceeding -8D , or other eye disease that impacts the outcome of vitrectomy surgery
- Patients with HIV
- Patients with history of drug abuse or alcoholism
- Patients participating in other drug or medical device clinical trials before screening for this trial
Trial locations and contacts
1 site in 1 country.
About this study
Two-arm, mono-center, prospective, interventional comparative case study to compare postoperative recovery between the 27G and larger gauge surgical approach.
Read the detailed description
A prospective randomized comparison of postoperative recovery between 27-gauge and larger gauge surgical approaches to evaluate efficiencies and postoperative outcomes of the surgical gauges. Fifty patients who were scheduled to undergo pars plana vitrectomy (PPV) for floaters or macular surgery were treated with either 27-gauge or 23-gauge techniques and assessed for efficiency of the procedures as well as a variety of postop indicators of pain and inflammation.
- Conditions
- Vitreoretinal Surgery
- Being tested
- vitrectomy (27G gauge or larger needle)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitrectomy (27G gauge or larger needle)Device
Also called vitrectomy surgery with 27G or larger needle technique
vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.
| Study group | Role | What they receive |
|---|---|---|
| 27 gauge needle vitrectomy surgery | Active comparator | ultra-small gauge Receives: Device: vitrectomy (27G gauge or larger needle) |
| larger than 27 gauge (23G or 25G) needle vitrectomy surgery | Active comparator | 23-gauge and 25-gauge instruments are a little larger in size Receives: Device: vitrectomy (27G gauge or larger needle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in post-operative outcome of pain
by assessing the amount of pain on a visual analogue scale (score 0-9)
Measured: day 1 postoperative
changes in post-operative outcome of redness
scoring the amount of redness on a scale 0-4 through eye photos
Measured: day 1 postoperative
changes in post-operative outcome in grading of anterior chamber cells
clinical assessment by slit lamp examination (Tyndall 0-3 and Cells 0-3)
Measured: day 1 postoperative
Secondary outcomes (3)
visual acuity
best corrected visual acuity in LogMar will be obtained to report the visual acuity
Measured: day 1 postoperative
intra-ocular pressure
Millimeter of Mercury pressure (mmHg) will be measured to report the intra-ocular pressure
Measured: day 1 postoperative
pain-assessment
a questionnaire with visual analogue scale will be used to assess the level of pain up to 1 week after the operation
Measured: 1 week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start5 Jun 2020
- Primary completion23 Jan 2021
- Study completion23 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreoretinal SurgeryStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Stalmans, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412525
- Sponsor's protocol ID
- S63610
- Status last verified
- Jun 2022
- First submitted
- 29 May 2020
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study 27G Vitrectomy vs Larger Gauge Surgery
- ClinicalTrials.gov ID
- NCT04412525
- Acronym / sponsor ID
- S63610
- Conditions
- Vitreoretinal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 23 Jan 2021 (actual)
- Study completion
- 23 Jan 2021 (actual)
- First posted
- 2 Jun 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.
Two-arm, mono-center, prospective, interventional comparative case study to compare postoperative recovery between the 27G and larger gauge surgical approach.
Detailed description
A prospective randomized comparison of postoperative recovery between 27-gauge and larger gauge surgical approaches to evaluate efficiencies and postoperative outcomes of the surgical gauges. Fifty patients who were scheduled to undergo pars plana vitrectomy (PPV) for floaters or macular surgery were treated with either 27-gauge or 23-gauge techniques and assessed for efficiency of the procedures as well as a variety of postop indicators of pain and inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 27 gauge needle vitrectomy surgery | Active comparator | Device: vitrectomy (27G gauge or larger needle)ultra-small gauge |
| larger than 27 gauge (23G or 25G) needle vitrectomy surgery | Active comparator | Device: vitrectomy (27G gauge or larger needle)23-gauge and 25-gauge instruments are a little larger in size |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged over 18
- No prior vitrectomy surgery in the study eye (for the same eye)
- No prior inclusion in this trial
- Scheduled for vitrectomy for floater removal or macular surgery (including macular holes) without endotamponades such as PFCL, Gas, Silicone oil). (Air tamponade is allowed )
Key exclusion criteria (5 listed)
- • Patients with serious heart, lung, liver, or kidney dysfunction
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 |
|---|---|---|
| vitrectomy (27G gauge or larger needle)Also: vitrectomy surgery with 27G or larger needle techniquevitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery. | Device | 27 gauge needle vitrectomy surgery, larger than 27 gauge (23G or 25G) needle vitrectomy surgery |
Primary outcome
changes in post-operative outcome of pain
Time frame: day 1 postoperative
by assessing the amount of pain on a visual analogue scale (score 0-9)
changes in post-operative outcome of redness
Time frame: day 1 postoperative
scoring the amount of redness on a scale 0-4 through eye photos
changes in post-operative outcome in grading of anterior chamber cells
Time frame: day 1 postoperative
clinical assessment by slit lamp examination (Tyndall 0-3 and Cells 0-3)
3 secondary outcomes
visual acuity
Time frame: day 1 postoperative
intra-ocular pressure
Time frame: day 1 postoperative
pain-assessment
Time frame: 1 week postoperative
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 11 Jul 2022.
- 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.
Peter Stalmans, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitrectomy (27G gauge or larger needle) in people with Vitreoretinal Surgery, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 inclusion and 5 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 11 Jul 2022. 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 Belgium. 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?
changes in post-operative outcome of pain (time frame: day 1 postoperative). The study lists 3 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 11 Jul 2022.