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

Completed

• Conditions: Eye Trauma

• 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

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