Wound ComplicationNCT04360603
The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia
A study testing 27G and 25G in people with Wound Complication and High Myopia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In recent decade, a major improvement in vitreoretinal surgery was the use of small gauge surgical systems that improved the safety of vitrectomy and also reduced the surgical time. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Wound Complication, High Myopia, Vitrectomy
- What is being tested?
- 27G and 25G
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2020to Aug 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Highly myopic patients (axial length 26~31mm)
- Diagnosed with vitreoretinal pathology that require vitrectomy
- Never received vitrectomy before
Who cannot join
- Surgical planning including scleral buckling during operation
- Surgical planning including combined phacoemulsification
- Surgical planning including the use of silicone oil and/or perfluorocarbon liquid
- Previous ocular surgery involving conjunctival manipulation and scarring such as pterygium removal/trabeculectomy
- Previous vitrectomy
- Previous ocular trauma involving corneal/corneoscleral/scleral/conjunctival full thickness laceration
- Medical history with known connective tissue disease(s)
- Age younger than 20 years old
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, 100
Chung-May Yang, 分機:65187；GSM:51547, chungmay@ntu.edu.tw
About this study
In recent decade, a major improvement in vitreoretinal surgery was the use of small gauge surgical systems that improved the safety of vitrectomy and also reduced the surgical time. However, there were still some concerns regarding small gauge vitrectomy system, especially 27-gauge system, in the stability of its instruments and the efficacy of removing vitreous during surgery. Although there were some studies that had reported the surgical outcomes of 27G vitrectomy system, none had focused on patients with high myopia. The highly myopic patients usually had thinner sclera, which was a risk factor for wound leakage after sutureless vitrectomy, they also had longer axial length which would make the surgical procedure more difficult especially in macular surgery.
Based on previous clinical finding, gas leakage was 36.4% in 25G , while 27G sclerotomy showing less leakage comparing to larger gauge sclerotomy, the investigators believe 27G may have its clinical advantages in overcoming the thinner sclera of high myopia, and show the superiority of leakage control.
Read more
Hypothesis:
The 27G vitrectomy system has lower sclerotomy wound leakage rate compared with 25G system
- Conditions
- Wound Complication, High Myopia, Vitrectomy
- Being tested
- 27G, 25G
- Keywords
- vitrectomy, high myopia, wound leakage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
27GDevice
using 27G vitrectomy system to perform standard transconjunctival sutureless vitrectomy
25GDevice
using 25G vitrectomy system to perform standard transconjunctival sutureless vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| 27 gauge system | Experimental | study group, using 27G vitrectomy system Receives: Device: 27G |
| 25 gauge system | Active comparator | control group, using 25G vitrectomy system Receives: Device: 25G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative sclerotomy site wound leakage
The incidence of intraoperative sclerotomy site wound leakage
Measured: immediately at the end of surgery
Secondary outcomes (5)
Incidence of postoperative sclerotomy site wound leakage
postoperative complication
Measured: post-operation day 1, 3, week 1, month 1, 3, 6
Incidence of hypotony
intraoperative and postoperative complication
Measured: post-operation day 1, 3, week 1, month 1, 3, 6
Incidence of endophthalmitis
postoperative complication
Measured: post-operation day 1, 3, week 1, month 1, 3, 6
Incidence of instrument bending
intraoperative complications
Measured: during operation
Incidence of subconjunctival hemorrhage
postoperative complication
Measured: post-operation day 1, 3, week 1, month 1, 3, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study startApr 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound ComplicationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Chung-May Yang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360603
- Sponsor's protocol ID
- 201907025RINB
- Status last verified
- Apr 2020
- First submitted
- 19 Apr 2020
- Last updated
- 24 Apr 2020
- 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 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia
- ClinicalTrials.gov ID
- NCT04360603
- Acronym / sponsor ID
- 201907025RINB
- Conditions
- Wound Complication, High Myopia, Vitrectomy
- Keywords
- vitrectomy, high myopia, wound leakage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Apr 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 24 Apr 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.
In recent decade, a major improvement in vitreoretinal surgery was the use of small gauge surgical systems that improved the safety of vitrectomy and also reduced the surgical time. However, there were still some concerns regarding small gauge vitrectomy system, especially 27-gauge system, in the stability of its instruments and the efficacy of removing vitreous during surgery. Although there were some studies that had reported the surgical outcomes of 27G vitrectomy system, none had focused on patients with high myopia. The highly myopic patients usually had thinner sclera, which was a risk factor for wound leakage after sutureless vitrectomy, they also had longer axial length which would make the surgical procedure more difficult especially in macular surgery.
Based on previous clinical finding, gas leakage was 36.4% in 25G , while 27G sclerotomy showing less leakage comparing to larger gauge sclerotomy, the investigators believe 27G may have its clinical advantages in overcoming the thinner sclera of high myopia, and show the superiority of leakage control.
Hypothesis:
The 27G vitrectomy system has lower sclerotomy wound leakage rate compared with 25G system
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 27 gauge system | Experimental | Device: 27Gstudy group, using 27G vitrectomy system |
| 25 gauge system | Active comparator | Device: 25Gcontrol group, using 25G vitrectomy system |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Highly myopic patients (axial length 26~31mm)
- Diagnosed with vitreoretinal pathology that require vitrectomy
- Never received vitrectomy before
Key exclusion criteria (8 listed)
- Surgical planning including scleral buckling during operation
- Surgical planning including combined phacoemulsification
- Surgical planning including the use of silicone oil and/or perfluorocarbon liquid
- Previous ocular surgery involving conjunctival manipulation and scarring such as pterygium removal/trabeculectomy
- Previous vitrectomy
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 |
|---|---|---|
| 27Gusing 27G vitrectomy system to perform standard transconjunctival sutureless vitrectomy | Device | 27 gauge system |
| 25Gusing 25G vitrectomy system to perform standard transconjunctival sutureless vitrectomy | Device | 25 gauge system |
Primary outcome
Incidence of intraoperative sclerotomy site wound leakage
Time frame: immediately at the end of surgery
The incidence of intraoperative sclerotomy site wound leakage
5 secondary outcomes
Incidence of postoperative sclerotomy site wound leakage
Time frame: post-operation day 1, 3, week 1, month 1, 3, 6
Incidence of hypotony
Time frame: post-operation day 1, 3, week 1, month 1, 3, 6
Incidence of endophthalmitis
Time frame: post-operation day 1, 3, week 1, month 1, 3, 6
Incidence of instrument bending
Time frame: during operation
Incidence of subconjunctival hemorrhage
Time frame: post-operation day 1, 3, week 1, month 1, 3, 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- 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.
Chung-May Yang, MD principal investigator
National Taiwan University 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 27G and 25G in people with Wound Complication and High Myopia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 8 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 24 Apr 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 Taiwan. 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 Tso-Ting Lai, MD (0972651992, b91401005@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intraoperative sclerotomy site wound leakage (time frame: immediately at the end of surgery). 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 24 Apr 2020.