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

Eye Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04733846
• Other study ID #: IRBN202021/CHUSTE
• Status: Completed
• Start date: March 18, 2020
• Est. completion date: December 5, 2021

Study information

• Verified date: January 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 5, 2021
• Est. primary completion date: December 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Emergencies
• Eye Trauma

Intervention

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

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

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