Eye TraumaNCT04733846
Treatment of Corneal Wounds Emergencies During the COVID-19 Shutdown: Absorbable 10-0 Vicryl Sutures as a Valuable Strategy.
An observational study of Eye Trauma, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Vicryl (polyglactin) 10-0 resorbable suture is rarely used, little known to ophthalmologists but may offer therapeutic and practical advantages in eligible cases of corneal trauma, particularly during a COVID-19 pandemic. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eye Trauma
- What is being tested?
- data collection
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2020to 5 Dec 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who had an emergency eye surgery in the Saint-Etienne University Hospital from 18/03/2020 to 05/12/2020
Who may be able to join
- Corneal penetrating injury and/or lamellar laceration
Who cannot join
- Corneal Penetrating injury trauma requiring necessarily ONLY Nylon 10-0
- Traumatism requiring necessarily a cryopreserved human amniotic membrane (for example)
- Traumatism eligible for biological glue (long-axis wound < 2 mm)
Trial locations and contacts
1 site in 1 country.
About this study
Vicryl (polyglactin) 10-0 resorbable suture is rarely used, little known to ophthalmologists but may offer therapeutic and practical advantages in eligible cases of corneal trauma, particularly during a COVID-19 pandemic.
This has imposed new sanitary restrictions : limited access to the operating room in ophthalmology only for functional emergencies and a drastically reduced capacity for external consultations in favor of teleconsultation. The aim of this study is to evaluate the Vicryl 10-0 (polyglactin 910) resorbable monofilament suture in corneal trauma, rather than classic Nylon 10-0: structural and functional results, and adaptation of postoperative follow-up during a sanitary crisis period.
- Conditions
- Eye Trauma
- Being tested
- data collection
- Keywords
- Corneal, penetrating injury, lamellar laceration, COVID, polyglactin, Vicryl
- Medical subject headings
- Eye Injuries, Wounds, Penetrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
Collection of clinical and paraclinical data during preoperative consultation Collection of clinical and paraclinical data during post-operative consultations Tele-consultation to determine if criteria for good healing / adherence, treatment tolerance / response to questions Remote follow-up 6 and 12 months after the trauma
| Study group | Role | What they receive |
|---|---|---|
| corneal trauma sutured with Vicryl 10-0 monofilament | corneal trauma sutured with Vicryl 10-0 monofilament will be included. They will have data collection of medical records. Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
change visual acuity (Snellen scale) from baseline and 2, 6, 12 and 18 months after the intervention
Collected in the medical record.
Measured: Months: 0, 2, 6, 12, 18
change Visual acuity (Parinaud scale) from baseline and 2, 6, 12 and 18 months after the intervention
Collected in the medical record.
Measured: Months: 0, 2, 6, 12, 18
Secondary outcomes (3)
Astigmatism (diopter)
Collected in the medical record. Measured by OCT-TOMEY-CASIA).
Measured: Months: 0, 2, 6, 12, 18
Number of postoperative external consultations
Collected in the medical record.
Measured: Months: 0, 2, 6, 12, 18
Adverse events
Collected in the medical record. All adverse events connecting to the eye surgery.
Measured: Months: 0, 2, 6, 12, 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start18 Mar 2020
- Primary completion5 Dec 2020
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye TraumaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibaut GARCIN, MD PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733846
- Sponsor's protocol ID
- IRBN202021/CHUSTE
- Status last verified
- Jan 2022
- First submitted
- 1 Feb 2021
- Last updated
- 29 Mar 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 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Corneal Wounds Emergencies During the COVID-19 Shutdown: Absorbable 10-0 Vicryl Sutures as a Valuable Strategy.
- ClinicalTrials.gov ID
- NCT04733846
- Acronym / sponsor ID
- IRBN202021/CHUSTE
- Conditions
- Eye Trauma
- Keywords
- Corneal, penetrating injury, lamellar laceration, COVID, polyglactin, Vicryl
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 5 Dec 2020 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 2 Feb 2021 (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.
Vicryl (polyglactin) 10-0 resorbable suture is rarely used, little known to ophthalmologists but may offer therapeutic and practical advantages in eligible cases of corneal trauma, particularly during a COVID-19 pandemic.
This has imposed new sanitary restrictions : limited access to the operating room in ophthalmology only for functional emergencies and a drastically reduced capacity for external consultations in favor of teleconsultation. The aim of this study is to evaluate the Vicryl 10-0 (polyglactin 910) resorbable monofilament suture in corneal trauma, rather than classic Nylon 10-0: structural and functional results, and adaptation of postoperative follow-up during a sanitary crisis period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| corneal trauma sutured with Vicryl 10-0 monofilament | – | Other: data collectioncorneal trauma sutured with Vicryl 10-0 monofilament will be included. They will have data collection of medical records. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had an emergency eye surgery in the Saint-Etienne University Hospital from 18/03/2020 to 05/12/2020
Key inclusion criteria (1 listed)
- Corneal penetrating injury and/or lamellar laceration
Key exclusion criteria (3 listed)
- Corneal Penetrating injury trauma requiring necessarily ONLY Nylon 10-0
- Traumatism requiring necessarily a cryopreserved human amniotic membrane (for example)
- Traumatism eligible for biological glue (long-axis wound < 2 mm)
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 |
|---|---|---|
| data collectionCollection of clinical and paraclinical data during preoperative consultation Collection of clinical and paraclinical data during post-operative consultations Tele-consultation to determine if criteria for good healing / adherence, treatment tolerance / response to questions Remote follow-up 6 and 12 months after the trauma | Other | corneal trauma sutured with Vicryl 10-0 monofilament |
Primary outcome
change visual acuity (Snellen scale) from baseline and 2, 6, 12 and 18 months after the intervention
Time frame: Months: 0, 2, 6, 12, 18
Collected in the medical record.
change Visual acuity (Parinaud scale) from baseline and 2, 6, 12 and 18 months after the intervention
Time frame: Months: 0, 2, 6, 12, 18
Collected in the medical record.
3 secondary outcomes
Astigmatism (diopter)
Time frame: Months: 0, 2, 6, 12, 18
Number of postoperative external consultations
Time frame: Months: 0, 2, 6, 12, 18
Adverse events
Time frame: Months: 0, 2, 6, 12, 18
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 29 Mar 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.
Thibaut GARCIN, MD PhD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Trauma, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 3 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 29 Mar 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 France. 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?
change visual acuity (Snellen scale) from baseline and 2, 6, 12 and 18 months after the intervention (time frame: Months: 0, 2, 6, 12, 18). The study lists 2 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 29 Mar 2022.