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

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: Eye Trauma
• Intervention / Treatment: Other: data collection

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • Chu Saint-Etienne

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

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	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	Collected in the medical record.	Months: 0, 2, 6, 12, 18

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Thibaut GARCIN, MD PhD, CHU de Saint-Etienne

Study record dates

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: COVID; Corneal; penetrating injury; lamellar laceration; polyglactin; Vicryl
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• 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