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

Completed

• Conditions: Eye Trauma
• Interventions: Other: data collection

• Registration Number: NCT04733846
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-18
• Primary Completion: 2020-12-05
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-02
• Study Completion: 2021-12-05
• Status Verified: 2022-01
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
corneal trauma sutured with Vicryl 10-0 monofilament	data collection	corneal trauma sutured with Vicryl 10-0 monofilament will be included. They will have data collection of medical records.

Primary Outcome Measures

Name	Time	Method
change visual acuity (Snellen scale) from baseline and 2, 6, 12 and 18 months after the intervention	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	Months: 0, 2, 6, 12, 18	Collected in the medical record.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France