Vitreoretinal Surgery23Gvs27GNCT04216108
Comparative Study 23G Versus 27G Vitrectomy
A study testing Vitrectomy (23G gauge needle) and Vitrectomy (27G gauge needle) in people with Vitreoretinal Surgery, run by Prof. Dr. Peter Stalmans at 1 site in Belgium.
Trial summary
Investigator-initiated, comparative double-arm, mono-center, prospective, interventional case study to determine whether ultra-small gauge surgery (27G gauge needle) improves postoperative outcome and patient morbidity. 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 (23G gauge needle) and Vitrectomy (27G gauge needle)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2018to 13 Mar 2020
- 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
- No prior inclusion in this trial
- Scheduled for vitrectomy for floater removal or macular surgery
Who cannot join
- Patients with serious heart, lung, liver, or kidney dysfunction
- Patients with proliferative diabetic retinopathy, endophthalmitis, uveitis and other eye disease that impacts the outcome of vitrectomy surgery Patients with HIV (Human Immune-deficiency Virus)
- Patients with history of drug abuse or alcoholism
- Patients participating in other drug or medical device clinical trials before screening for this trial
- Pregnancy, preparation for pregnancy during clinical trial, or breastfeeding
- Belief by the investigator that a patient's condition would hinder the clinical trial, such as a patient prone to mental stress, loss of control of mood, or depression
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospitals Leuven (UZ Leuven)
Leuven, Vl-Brabant, 3000
About this study
Investigator-initiated, comparative double-arm, mono-center, prospective, interventional case study to determine whether ultra-small gauge surgery (27G gauge needle) improves postoperative outcome and patient morbidity.
- Conditions
- Vitreoretinal Surgery
- Being tested
- Vitrectomy (23G gauge needle), Vitrectomy (27G gauge needle)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrectomy (23G gauge needle)Device
Vitrectomy surgery with 23G gauge needle technique
Vitrectomy (27G gauge needle)Device
Vitrectomy surgery with 27G gauge needle technique
| Study group | Role | What they receive |
|---|---|---|
| 23G gauge needle vitrectomy surgery | Experimental | Not described Receives: Device: Vitrectomy (23G gauge needle) |
| 27G gauge needle vitrectomy surgery | Experimental | Not described Receives: Device: Vitrectomy (27G gauge 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: 1 week
Changes in post-operative outcome of redness
Scoring the amount of redness on a scale 0-4 through eye photos
Measured: 1 week
Changes in post-operative outcome of measured inflammation
Measuring the amount of inflammation by measurement of Flare (photon/ms)
Measured: 1 week
Changes in post-operative outcome in grading of anterior chamber cells
Clinical assesment by slit lamp (Tyndall 0 - 3 and Cells 0 - 3)
Measured: 1 week
Secondary outcomes (3)
Post-operative parameter: Visual acuity
Best corrected visual acuity in LogMar will be obtained to report the visual acuity.
Measured: 1 week
Post-operative parameter: Intraocular pressure
Millimeter of Mercury pressure (mmHG) will be measured to report the intraocular pressure.
Measured: 1 week
Post-operative parameter: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Dec 2018
- Primary completion5 Mar 2020
- Study completion13 Mar 2020
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.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Peter Stalmans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Peter Stalmans, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Peter Stalmans, MD Phd, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216108
- Sponsor's protocol ID
- S61408
- Acronym
- 23Gvs27G
- Status last verified
- May 2020
- First submitted
- 15 Jul 2019
- Last updated
- 8 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study 23G Versus 27G Vitrectomy
- ClinicalTrials.gov ID
- NCT04216108
- Acronym / sponsor ID
- 23Gvs27G / S61408
- Conditions
- Vitreoretinal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Prof. Dr. Peter StalmansUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 2 Jan 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.
Investigator-initiated, comparative double-arm, mono-center, prospective, interventional case study to determine whether ultra-small gauge surgery (27G gauge needle) improves postoperative outcome and patient morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 23G gauge needle vitrectomy surgery | Experimental | Device: Vitrectomy (23G gauge needle) |
| 27G gauge needle vitrectomy surgery | Experimental | Device: Vitrectomy (27G gauge needle) |
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
- No prior inclusion in this trial
- Scheduled for vitrectomy for floater removal or macular surgery
Key exclusion criteria (6 listed)
- Patients with serious heart, lung, liver, or kidney dysfunction
- Patients with proliferative diabetic retinopathy, endophthalmitis, uveitis and other eye disease that impacts the outcome of vitrectomy surgery Patients with HIV (Human Immune-deficiency Virus)
- Patients with history of drug abuse or alcoholism
- Patients participating in other drug or medical device clinical trials before screening for this trial
- Pregnancy, preparation for pregnancy during clinical trial, or breastfeeding
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 (23G gauge needle)Vitrectomy surgery with 23G gauge needle technique | Device | 23G gauge needle vitrectomy surgery |
| Vitrectomy (27G gauge needle)Vitrectomy surgery with 27G gauge needle technique | Device | 27G gauge needle vitrectomy surgery |
Primary outcome
Changes in post-operative outcome of pain
Time frame: 1 week
By assessing the amount of pain on a visual analogue scale (score 0 - 9)
Changes in post-operative outcome of redness
Time frame: 1 week
Scoring the amount of redness on a scale 0-4 through eye photos
Changes in post-operative outcome of measured inflammation
Time frame: 1 week
Measuring the amount of inflammation by measurement of Flare (photon/ms)
Changes in post-operative outcome in grading of anterior chamber cells
Time frame: 1 week
Clinical assesment by slit lamp (Tyndall 0 - 3 and Cells 0 - 3)
3 secondary outcomes
Post-operative parameter: Visual acuity
Time frame: 1 week
Post-operative parameter: Intraocular pressure
Time frame: 1 week
Post-operative parameter: Pain assessment
Time frame: 1 week
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 8 May 2020.
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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, MD 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 (23G gauge needle) and Vitrectomy (27G gauge needle) in people with Vitreoretinal Surgery, run by Prof. Dr. Peter Stalmans 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 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 8 May 2020. 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: 1 week). The study lists 4 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 8 May 2020.