Treatment of Corneal Wounds Emergencies During the COVID-19 Shutdown: Absorbable 10-0 Vicryl Sutures as a Valuable Strategy.

March 14, 2022 updated by: Centre Hospitalier Universitaire de Saint Etienne

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France
        • CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who had an emergency eye surgery in the Saint-Etienne University Hospital from 18/03/2020 to 05/12/2020

Description

Inclusion Criteria:

  • Corneal penetrating injury and/or lamellar laceration

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: data collection
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Months: 0, 2, 6, 12, 18
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.
Months: 0, 2, 6, 12, 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Astigmatism (diopter)
Time Frame: Months: 0, 2, 6, 12, 18
Collected in the medical record. Measured by OCT-TOMEY-CASIA).
Months: 0, 2, 6, 12, 18
Number of postoperative external consultations
Time Frame: Months: 0, 2, 6, 12, 18
Collected in the medical record.
Months: 0, 2, 6, 12, 18
Adverse events
Time Frame: Months: 0, 2, 6, 12, 18
Collected in the medical record. All adverse events connecting to the eye surgery.
Months: 0, 2, 6, 12, 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Thibaut GARCIN, MD PhD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2020

Primary Completion (Actual)

December 5, 2020

Study Completion (Actual)

December 5, 2021

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (Actual)

February 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN202021/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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